einstein healthcare network cancer center active … clinical trials.pdf · gastrointestinal –...

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EINSTEIN HEALTHCARE NETWORK CANCER CENTER

ACTIVE CLINICAL TRIALS

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TABLE OF CONTENTS

PAGE

Studies by Organ/System

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Brain

4 - 6

Breast – Neoadjuvant/Adjuvant

6

Breast – Advanced/Metastatic

7-8

Gastrointestinal – Colorectal – Adjuvant

9 Gastrointestinal –Advanced, Metastatic

10

Gastrointestinal –Hepatocellular

11 Gastrointestinal –Pancreatic

12-13 Genitourinary – Prostate

14 Gynecological

15-16

Head and Neck

17 Myeloma

18-20

Lung – NSCLC

21-22

Lung – SCLC/Thymoma, Thymic Carcinoma/Mesothelioma

23-24

25

Supportive care

Multiple cancer diagnoses

26

27

Trials pending activation

ECOG Path. Coordinating Ctr Information “NEW” 10/24/2014

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BRAIN PROTOCOL CONTACTS

Radiation Oncology Investigator – Kenneth Zeitzer, MD 215-456-6280

Coordinator – Jeff Mealey, RN 215-456-6316

No active studies at this time.

4

BREAST PROTOCOL CONTACTS

MEDICAL ONCOLOGY Investigator – Mark S. Morginstin, DO 215-456-3880

Coordinator – Joann R. Ackler, RN, OCN, CCRP 215-456-8295

RADIATION ONCOLOGY Investigator – Angelica T. Montesano, MD 215-456-6280

Coordinator – Jeff Mealy, RN 215-456-6316

STUDY# ADJUVANT

TITLE and ELIGIBILITY CRITERIA THERAPY

NRG BR-003/

CIRB-005

# Pts: _____

Initial approval 3/21/2016

CIRB Approval expires 2/17/17

A Randomized Phase III Trial of Adjuvant Therapy

Comparing Doxorubicin Plus Cyclophosphamide Followed by

Weekly Paclitaxel with or without Carboplatin for Node-

Positive or High-Risk Node Negative Invasive Breast Cancer

Eligibility: Unilateral breast IDC: pT1-3; pN0 – pN3b,

underwent mastectomy or clear margins on lumpectomy/re-

excision; ER, PR, & HER2 negative (please see pgs. 14-15 of

protocol for specifics). < 60 days from last surgery to

randomization. Adequate organ function/lab values (see pgs. 15

& 16 of protocol); Please refer to section 3.3, pgs. 16 & 17 for

exclusion criteria details.

Arm 1:

Doxorubicin 60 mg/M2 IV

Cyclophosphamide 600 mg/m2 IV

Q 2 Weeks X 4 cycles

Followed by:

Paclitaxel 80 mg/m2 IV weekly x 12 doses

Arm 2:

Doxorubicin 60 mg/M2 IV

Cyclophosphamide 600 mg/m2 IV

Q 2 Weeks X 4 cycles

Followed by:

Paclitaxel 80 mg/m2 IV weekly x 12 doses and

Carboplatin AUC 5 IV Q 3 weeks

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STUDY# ADJUVANT


RTOG 1014

A Phase II study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma Closed to accrual 6/18/13

Partial Breast Re-Irradiation (PBrI)

3D-Conformal External Beam

1.5 GY x 15 (BID) to 45 Gy Total

Patient Population:

� Histopathologic confirmation via lumpectomy of local in-breast

ipsilateral recurrence

� Final breast surgery (lumpectomy and/or final re-excision) within

42 days prior to study entry;

� Initial lumpectomy followed by whole breast radiation >1 year

prior to study entry;

� Ipsilateral breast mammogram and MRI within 120 days prior to

study entry. Contralateral breast

mammogram within 12 months of study entry.

� Negative histologic margins of resection, no tumor on ink,

following breast-preserving surgery of local recurrence.

Partial Breast Re-Irradiation (PBrI)

3D-Conformal External Beam

1.5 GY x 15 (BID) to 45 Gy Total

RTOG 1005

A PHASE III TRIAL OF

ACCELERATED WBI WITH

HYPOFRACTIONATION PLUS

CONCURRENT BOOST

Vs. STANDARD WBI

PLUS SEQUENTIAL BOOST FOR

EARLY-STAGE BREAST CANCER

Patient Population:

pStage 0, I, II Breast Cancer resected by lumpectomy

ypStage 0, I,II Breast Cancer resected by lumpectomy that

followed neoadjuvant systemic therapy

ARM 1: Standard fractionation

Whole Breast 50.0 Gy/25 fractions/2.0 Gy daily

Optional fractionation of 42.7Gy in 16 fractions permissible

Sequential Boost 12.Gy/6 fractions/2.0 Gy daily or

14.0Gy/7fractions/2Gy daily

ARM 2: Hypofractionation (15 fractions total)

Whole Breast 40 Gy/15 fractions/2.67 Gy daily

Concurrent boost 48.0 Gy/3.2 Gy daily

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BREAST – Advanced/Metastatic E2112

CIRB-004

# Pts. = _____

Initial NCI-CIRB AEHN approval

2/4/2016

Expires May 20, 2016

A Randomized Phase III Trial of Endocrine Therapy plus

Entinostat/Placebo in Postmenopausal Patients with

Hormone Receptor-Positive Advanced Breast Cancer

Eligibility:ER or PR (+) hist. confirmed adeno ca; must be HER2

neg.; Stage III/locally advanced or metastatic not suitable for

therapy of curative intent. Meas or non-meas disease evaluated <

4 wks. Please see eligibility checklist for complete entry criteria

[protocol section 3.1, pages 19-22].

Arm A:

Exemestane 25 mg PO daily x 28 days

Entinostat 5 mg PO days 1, 8, 15, & 22

Arm B:

Exemestane 25 mg PO daily x 28 days

Placebo 5 mg PO days 1, 8, 15, & 22

A cycle = 28 days

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GI PROTOCOL CONTACTS – ANAL, COLORECTAL, ESOPHAGEAL, GASTRIC,

HEPATOCELLULAR, PANCREATIC, & GIST

Medical Oncology: Investigator – John Leighton, MD 215-456-3880

Coordinator – Joann R. Ackler, RN, OCN, CCRP 215-456-8295

Radiation Oncology: Investigator – Kenneth Zeitzer, MD 215-456-6285

Coordinator – Jeff Mealy, RN 215-456-6316

GASTROINTESTINAL STUDIES – Esophagus & Gastric – No active studies at this time.

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GASTROINTESTINAL – Adjuvant/Resected Colon

C80702

Stage III

(H) N-4285

# Pts. 5

Accrual goal = 10 / 2,500

Study Nurse: Joann Ackler

Closed to accrual

11.20.15

Update #7 approved 3/16/2015

IRB Approval Expires

September 17, 2016

Phase III Trial of 6 vs. 12 Treatments of Adjuvant Folfox +

Celecoxib/Placebo for Patients with Resected Stage III Colon

Cancer

Eligibility: Hist. proven Adenocarcinoma; margin > 12 cm from

anal verge & completely resected – R0 resection must be in

operative report; > 1 + lymph node or N1C [see AJCC v. 7];

synchronous colon primaries OK; PS 0-2; adequate hematologic,

renal, & hepatic function; NO -- evidence of residual nodal or

metastatic disease; NSAIDS or ASA use > 3 x/wk; prior or

concurrent malignancy except in situ skin cancer unless NED > 5

yrs; neuro-toxicity > Gr 2; history UGI ulcers, bleed, or

perforation x 3yrs; uncontrolled HTN, unstable angina, any history

of MI or CVA, NYHA class III/IV CHF; allergy to sulfonamides,

celecoxib, NSAIDS.

Arm A: 6 cycles FOLFOX* + Celecoxib/placebo

(400 mg daily) Q 2 weeks

Arm B: 12 cycles FOLFOX* +

Celecoxib/placebo (400 mg daily) Q 2 weeks

*Oxaliplatin – 85 mg/m2 IV over 2 hrs, followed

by

*Leucovorin 400 mg/m2 IV over 2 hrs, followed

by

*5-FU 400 mg/m2 IV bolus, then 2400 mg/m

2

CIV over 46-48 hrs.

NOTE: Treatment must begin > 21 and < 56

days after definitive resection.

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GASTROINTESTINAL – Metastatic Colorectal

STUDY# TITLE and ELIGIBILITY CRITERIA THERAPY

2012-PT023-V3.4 WIRB # 20120762

# Pts. =1 (under v2.4); 3 (under v3.4)

Total = 4

Accrual goal = 8 / 650

Study nurse: Joann Ackler

WIRB Initial Approval Date –

5.13.2013,

Version 3.4 -9.22.2015

Expires 5.17.2016

Phase III Double-Blinded, Placebo Controlled Study of

XilonixTM

for Improving Survival in Metastatic Colorectal

Cancer Patients with Cachexia

Eligibility: Path. Confirmed metastatic or unresectable, refractory

colon cancer (refer to protocol pg 30 for required prior therapies);

PS = 0-2; Weight loss in past 6 months must be < 20%; most

recent anti-cancer therapy must be > 2; adequate organ function –

see specific lab parameters pg 29; serum K

+ & Mg

++ levels must

be WNL – OK to replenish to normal prior to enrollment; refer to

pg 31 for specific cardiac status criteria; NO active infections,

HIV, Hepatitis B or C; NO TB history (latent or active) or +

IGRA; AEs from prior trt must be < grade 1.

Restricted therapies:at least 2 weeks since last therapy

including; XRT, chemotherapy, immunotherapy, surgery,

hormonal therapy or targeted biologics; at least 4 weeks since

agents that target IL-1/TNF-alpha.

Study drug (MABp1/placebo)

7.5 mg/kg IV over 1 hour (+/- 15 minutes)

Q 2 weeks

1 hour observation will follow each infusion

*all subjects will receive BSC (best supportive care)

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GASTROINTESTINAL STUDIES –HEPATOCELLULAR – No active trials effective 11/19/2014

STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY

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GASTROINTESTINAL STUDIES-PANCREATIC


RTOG 0848

Study Nurse:

A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant

Treatment for Patients with Resected Head of Pancreas Adenocarcinoma

Primary head of pancreas invasive adenocarcinoma resected (i.e., removal of

all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a

pylorus preserving pancreaticoduodenectomy; IPMN are eligible; T1-3, N0-1,

M-0 eligible.

Ist Randomization

Arm 1: gemcitabine x 5 cycles

Arm 2: gemcitabine + erlotinib x 5 cycles

Evaluate to confirm no progression

2nd

Randomization

Arm 3: 1 cycle same chemotherapy as first

randomization treatment arm

Arm 4: 1 cycle same chemotherapy as first

randomization treatment arm followed by XRT

+ capecitabine or 5-FU

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GU PROTOCOL CONTACTS- Bladder, Prostate, Renal

RADIATION ONCOLOGY: Investigator – Kenneth L. Zeitzer, MD 215-456-6280

Coordinator – Jeff Mealey, RN 215-456-6316

ECOG/Other: Investigator – William Tester, MD 215-456-3880

Coordinator – Joann Ackler RN, OCN 215-456-8295

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Prostate

STUDY #


RTOG 0534 A PHASE III TRIAL OF SHORT TERM ANDROGEN

DEPRIVATION WITH PELVIC LYMPH NODE OR PROSTATE

BED ONLY RADIOTHERAPY (SPPORT) IN PROSTATE

CANCER

PATIENTS WITH A RISING PSA AFTER RADICAL

PROSTATECTOMY

Lymph node negative adenocarcinoma of the prostate treated with

radical prostatectomy

Post-radical prostatectomy PSA of ≥ 0.1 - < 2.0 ng/mL; pathologic

T3N0/Nx disease or pathologic T2N0/Nx disease, with or without a

positive prostatectomy surgical margin;

Gleason ≤ 9

Arm 1: PBRT alone PBRT 64.8-70.2 Gy

Arm 2: PBRT + NC-STAD PBRT 64.8-70.2 Gy + NC-STAD

for 4-6 months, beginning 2 months before RT

Arm 3: PLNRT + PBRT + NC-STAD

PLNRT to 45 Gy and PBRT to 64.8-70.2 Gy,

NC-STAD for 4-6 months, beginning 2 months before RT

RTOG 0938 A Randomized Phase II Trial Of Hypofractionated Radiotherapy For

Favorable Risk Prostate Cancer-RTOG CCOP Study

Histologically confirmed diagnosis of adenocarcinoma of the

prostate within 180 days of randomization; Gleason

scores 2-6; Clinical stage T1-2a; PSA < 10 ng/mL (PSA should not

be obtained within 10 days after prostate

biopsy).

Treatment techniques/machine

1. All linear accelerator based treatment

(excluding Cyberknife)

2. Cyberknife

3. Protons

Arm 1

36.25 Gy in 5 fractions of 7.25 Gy over two

and a half weeks (in 15-17 days)*

Arm 2

51.6 Gy in 12 daily fractions of 4.3 Gy over

two and a half weeks (in 16-18 days)*

RTOG 0815 H(N)

Study Nurse: Jeff Mealey, RN

A Phase III Prospective Randomized Trial Of Dose-Escalated

Radiotherapy With Or Without Short-Term Androgen Deprivation

Therapy For Patients With Intermediate-Risk Prostate Cancer

Intermediate risk for recurrence as determined by having one or

more of the following: Gleason Score 7; PSA >10 but <20; Clinical

Stage T2b-T2c. Clinically negative lymph nodes as established by

imaging (pelvic +/- abdominal CT or MRI), nodal sampling, or

dissection within 60 days prior to registration, except as noted in

protocol Section 3.1.2. No evidence of bone metastases (M0) on

bone scan

Stratify by Number of Risk Factors; Comorbidity Status; RT

Modality

Arm 1: Dose-escalated RT alone

Arm 2: Dose-escalated RT combined with short-term (6

months) androgen blockade (LHRH agonist + antiandrogen)

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GYNECOLOGIC

PROTOCOL CONTACTS RADIATION ONCOLOGY: Investigator – Kenneth L. Zeitzer, MD 215-456-6280 Coordinator – Jeff Mealey, RN 215-456-6316

CTSU/GOG/OTHER: Investigator – Claudia Dourado, MD 215-456-3880

Coordinator –

No Active Studies at this time

GYN- CERVICAL STUDY #



GYN-ENDOMETRIAL/PERITONEAL/OVARIAN

STUDY #


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Head & Neck Studies-

RADIATION ONCOLOGY Investigator: Kenneth Zeitzer, MD 215-456-6280

Coordinator: Jeff Mealey, RN 215-456-6316 HEAD & NECK

STUDY #


RTOG 0920

A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for

Locally-Advanced Resected Head and Neck Cancer

Pathologically (histologically) proven diagnosis of squamous cell carcinoma

(including variants such as verrucous carcinoma, spindle cell carcinoma,

carcinoma NOS, etc.) of the head/neck (oral cavity, oropharynx or larynx);

Clinical stage T1, N1-2 or T2-3, N0-2, M0 including no distant metastases;

Gross total resection of the primary tumor with curative intent must be completed

within 7 weeks of registration with surgical pathology demonstrating one or

more of the following "intermediate" risk factors:

Perineural invasion;

Lymphovascular invasion;

Single lymph node > 3 cm or > 2 lymph nodes (all < 6 cm) [no

extracapsular extension];

Close margin(s) of resection, defined as cancer extending to within 5

mm of a surgical margin;

T3 or microscopic T4a primary tumor (Note: Gross T4a or T4b is

ineligible);

T2 oral cavity cancer with > 5 mm depth of invasion.

Arm 1: Radiation Therapy Alone, 2 Gy/day, in

30 fractions for a total of 60 Gy*

Arm 2: Radiation Therapy + Cetuximab

At least 5 days prior to RT: Cetuximab:

Initial dose, 400 mg/m2

RT: 2 Gy/day in 30 fractions for a total

of 60 Gy* plus cetuximab, 250

mg/m2/week x 6 weeks

plus cetuximab: 250 mg/m2/week x 4

weeks post-RT

*IMRT is mandatory. Dose is 60 Gy

prescribed to at least 95% of the PTV. If

IGRT is used, it should be daily to assure that

error/variance is < 3.5 mm. Note: 66 Gy is

permitted and optional.

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STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY RTOG 1016 Phase III Trial of Radiotherapy Plus Cetuximab Versus

Chemoradiotherapy in HPV-Associated Oropharynx Cancer

Patients must be positive for p16, determined by the Innovation Center

CLIA lab at The Ohio

State University (OSU) prior to Step 2 registration (randomization); see 10.2

for details of

tissue submission. Patients must consent to submission of tissue for this

analysis. Patients also

must consent to provide their smoking history by completing that portion of the

computer-assisted self

interview (CASI) head and neck risk factor survey tool.

For this study, IMRT is mandatory. IGRT credentialing is mandatory when

using PTV margins < 5

mm. See Section 5.0 for required pre-registration credentialing for IMRT (and

for IGRT, if used for

margin reduction).

Patient Population: (See Section 3.0 for Eligibility)

Squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate,

or oropharyngeal walls); stage

T1-2, N2a-3, or T3-4 any N; patient tumor must be p16 positive

Arm 1:

Accelerated IMRT, 70 Gy for 6 weeks

+ high dose DDP (100 mg/m2) Days 1 and 22

(Total: 200 mg/m2)

Arm 2:

Accelerated IMRT, 70 Gy for 6 weeks

+ 8 doses of cetuximab (400 mg/m2) loading

dose pre-IMRT, 250 mg/m2 weekly during

IMRT,and for 1 week after IMRT)

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HEMATOLOGIC PROTOCOL CONTACTS

MULTIPLE MYELOMA

PROTOCOL CONTACTS RADIATION ONCOLOGY: Investigator – Kenneth L. Zeitzer, MD 215-456-6280 Coordinator – 215-456-6316

CTSU/ECOG/OTHER: Investigator – Gabor Varadi, MD 215-456-3880

Coordinator – Joann Ackler, RN OCN 215-456-8295


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LUNG PROTOCOL CONTACTS

NSCLC, SCLC

RTOG: Investigator – Kenneth Zeitzer, MD 215-456-6280

Coordinator – Jeffrey Mealey, RN 215-456-6316

ECOG/Others: Investigators – William Tester, MD 215-456-3880

John Leighton, MD 215-827-1570

Coordinators – Joann Ackler RN, OCN, CCRP 215-456-8295

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LUNG – NSCLC: Adjuvant


A151216/ALCHEMIST

CIRB-001

Main Study

# Pts. = ___

NCI-CIRB Approval

Expires: 11/18/2016

Adjuvant Lung Cancer Enrichment Marker Identification and

Sequencing Trial (ALCHEMIST)

Eligibility: Completely resected stage IB (> 4cm), II or IIIA non-

squamous NSCLC; adequate FFPE tissue available for central EGFR and

ALK genotyping – Section 3.1, pages 7-8; PS = 0-1; NO neo-adjuvant

therapy for this lung cancer; NO prior treatment targeting EGFR or ALK;

NO second primary lung cancer (considered concurrent malignancy).

If no adjuvant therapy, register patient < 75 days following surgery

If adjuvant chemo. Only, register patient < 165 days following surgery

If adjuvant combination chemo-xrt, register patient < 225 days following

surgery.

A081105/Erlotinib Sub-study

to ALCHEMIST

CIRB-002

# Pts. = ___

NCI-CIRB Approval

Expires: 11/18/2016

Randomized Double Blind Placebo Controlled Study of Erlotinib or

Placebo in Patients with Completely Resected Epidermal Growth

Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer

(NSCLC)

Eligibility: Previously registered to ALCHEMIST w/EGFRexon 19

deletion or L858R mutation; Only prior in situ carcinomas or non-

melanoma skin cancers allowed; NO history of cornea abnormalities

See protocol pages 11-12 for complete list of entry criteria & time to

randomization

Erlotinib/placebo 150 mg/day

1 cycle = 21 days

Duration = up to 2 years if no recurrence or excessive toxicity

E4512/ Crizotinib Sub-study

to ALCHEMIST

CIRB-003

# Pts. = ___

NCI-CIRB Approval

Expires: 6/3/2016

A Phase III Double-Blind Trial for Surgically Resected Early Stage

Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients

with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK)

Fusion Protein

Eligibility: Previously registered to ALCHEMIST; EML4-ALK fusion

gene positive; NO known interstitial fibrosis or interstitial lung disease;

NO use of substances that are potent CYP3A4 inhibitors or inducers (see

Appendix V). See protocol pages 13 -17 for complete entry criteria.

Crizotinib/placebo 250 mg PO BID (Twice a day)

1 cycle = 21 days

Duration = up to 2 years if no recurrence or excessive toxicity

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Locally Advanced STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY

RTOG 0839

RANDOMIZED PHASE II STUDY OF PRE-OPERATIVE

CHEMORADIOTHERAPY +/- PANITUMUMAB FOLLOWED

BY

CONSOLIDATION CHEMOTHERAPY IN POTENTIALLY

OPERABLE LOCALLY

ADVANCED (STAGE IIIA, N2+) NON-SMALL CELL LUNG

CANCER

Pathologically proven diagnosis Stage IIIA (T1-T3) with a

single primary lung parenchymal lesion and N2 positive

ipsilateral mediastinal nodes

Randomize:

Arm 1: Induction Chemoradiation

Paclitaxel & Carboplatin: 1x/week for 6 weeks

Concurrent RT: 2 Gy/day, 5x/week, for 6 weeks, for a total of 60

Gy

Arm 2: Induction Chemoradiation and Panitumumab

Panitumumab 1x/week for 6 weeks

Paclitaxel & Carboplatin: 1x/week for 6 weeks

Concurrent RT: 2 Gy/day, 5x/week, for 6 weeks, for a total of 60

Gy

All Patients

Reassessment 4 weeks after Induction treatment

Resectable Patients with No Disease

Progression

Surgery within 2 weeks of reassessment

and within 6 weeks of completion of

induction treatment

Inoperable Patients

(inoperable for medical, anatomical, or other reasons)

with No Disease Progression

Patient proceeds to consolidation treatment

within 6 weeks of completion of

induction treatment

Arms 1 and 2: Consolidation Chemotherapy

Paclitaxel & Carboplatin: q21 days x 2

RTOG 0813 SEAMLESS PHASE I/II STUDY OF STEREOTACTIC LUNG

RADIOTHERAPY (SBRT) FOR EARLY STAGE, CENTRALLY

LOCATED, NON-SMALL CELL LUNG CANCER (NSCLC) IN

MEDICALLY INOPERABLE PATIENTS

Patients with stage T1-2, N0, M0, non-small cell lung cancer,

tumor size ≤ 5 cm, who are not candidates for a

complete surgical resection in the opinion of a thoracic

surgeon; only patients with tumors within or touching

the zone of the proximal bronchial tree or adjacent to

mediastinal or pericardial pleura.

Escalating dose levels; at all levels, patients will receive q 2 day

fractionation X 5 fractions over 1.5-2 weeks

LUNG – NSCLC: Advanced/Metastatic (continued)

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STUDY #


E5508

NSCLC Stage IV, 1st Line

(H) N-4269


# Pts: 14


Addendum #10 approved 10/21/14

Administrative changes only

Notice: Step 1 registration closed

to accrual 5.8.15

IRB Approval expires

May 14, 2016

Randomized Phase III Study of Maintenance Therapy with

Bevacizumab, Pemetrexed, or a combination of Bev + Pemetrexed

Following Carboplatin, Paclitaxel & Bevacizumab for Advanced

NSCLC

NSCLC (non-squamous); Stage IV [M1a & M1b or recurrent); PS

= 0-1; Prior adjuvant chemo OK if > 12 months prior to study –

NO prior use of paclitaxel, pemetrexed, or bevacizumab;

NO prior chemo for advanced NSCLC; NO hemoptysis < 4

wks (1/2 tsp.); NO cavitary lung lesions; Treated brain

metastases OK per amendment #7; Prior XRT OK if > 3 wks.

prior to study; adequate heme., renal, & hepatic function; BP

<150/100 @ baseline; NO history of thrombotic or bleeding

disorders < 12 months. NO pre-menopausal women. See

eligibility checklist for complete list of bevacizumab-related

criteria.

Induction:

Paclitaxel 200 mg/m2 IV +

Carboplatin AUC 6 IV +

Bevacizumab 15 mg/kg IV

Q 3 weeks X 4 cycles

Maintenance:

Randomized if SD or PR:

Arm A: Bevacizumab 15 mg/kg IV

Arm B: Pemetrexed 500 mg/M2 IV

Arm C: Bev plus Pem 500 mg/M2 IV

Q 3 weeks until PD

M14-359 (AbbVie)

HN-4708


# Pts:_____


Amendment 3 approved9.4.15;

additional ICF language approved

11.20.15

IRB approval expires

December 27, 2016

Randomized, Open-label. Multicenter, Phase III Trial Comparing

Veliparib Plus Carboplatin and Paclitaxel versus Investigator’s

Choice of Standard Chemotherapy in Subjects Receiving First

Cytoxic Chermotherapy for Metastatic or Advanced Non-squamous

NSCLC and who are current or former smokers*

Eligibility: NSCLC – hist/cyt. confirmed & at least predominantly

non-squamous; Must know EGFR/ALK status: if EGFR mutated

or with ALK gene rearrangement, must have progressed after 1st

line targeted therapy. > 1 meas. Lesion by RECIST; PS 0-1;

adequate organ function – see lab criteria, protocol page 6; NO:

peripheral neuropathy > gr.2, NO CNS mets NO seizures < 12

months before study entry; NO prior trt for NSCLC except neo-

adj. or adjuvant therapy > 12months before study entry. Any ext.

beam RT [thoracic] must be completed by 4 weeks or if to bone by

2 weeks before study entry. NO prior treatment with a PARP

inhibitor. NO hist. of other cancer < 3years except in situ cancers

considered cured.

*Defined as currently smoking –or- > 100 smoking events lifetime

and not smoked in past 12 months

Veliparib (ABT-888): 120 mg BID

Days -2 thru 5

Reference (Investigator’s choice) therapy x 6

cycles

Carboplatin: AUC 6 Day 1

Paclitaxel: 200 mg/m2 Day 1

Pemetrexed: 500 mg/m2

Cisplatin: 75 mg/m2

Maintenance Pemetrexed if suitable

1 cycle = 21 days

22

LUNG- SCLC –Limited Stage


RTOG 0538

CALGB 30610

PHASE III COMPARISON OF THORACIC

RADIOTHERAPY REGIMENS IN PATIENTS WITH

LIMITED SMALL CELL LUNG CANCER ALSO

RECEIVING CISPLATIN AND ETOPOSIDE

No prior chemotherapy or radiotherapy for SCLC.

No prior mediastinal or thoracic radiotherapy

Patients with complete surgical resection of disease are not

eligible.

Schema (1 cycle = 21 days)

Patients will receive 4 cycles of chemotherapy on all arms

Part I:

Arm A:

Radiotherapy (every day, Monday-Friday, for a total of 3 weeks)

XRT: 45 Gy BID (1.5 Gy/fx) starting on day 1 of Cycle 1 or 2, every day, for 3 weeks

Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks)

Cisplatin 80 mg/m2 IV on day 1, every 21 days

Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days

Arm B:


XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks




Arm C:


XRT: 61.2 Gy Concomitant boost: QD (1.8 Gy/fx), starting on day 1 of Cycle 1 or 2,

every day, for 16 days of treatment; then BID (1.8 Gy/fx) for 9 days of treatment




Prophylactic cranial irradiation (PCI) should be offered to all patients with a complete or

near complete response (see Section 8.2.9 for further details).

Part II: Based on the results of Part I, the experimental arm with the higher rate of toxic

events will be discontinued and patients will be randomized as follows:

Arm A:


XRT: 45 Gy BID (1.5 Gy/fx) for 3 weeks, starting on day 1 of Cycle 1 or 2



Etoposide 100 mg/m2 IV over 60-120 minutes on days 1, 2, and Register/ 3, every 21 days

Arm B or C, depending on which arm is less toxic.

Prophylactic cranial irradiation (PCI) should be offered to all patients with a complete or

near complete response (see Section 8.2.9 for further details).

23

LUNG –Small Cell Extensive Stage – No active studies at this time STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY

24

Supportive Care/Observational Studies

STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY Incyte INCB-MA-PV-401

- P. Vera Observational Study

HN-4662 EXP

# Patients = 14

Accrual goal = 27/2,000

PI – Dr. Goldstein

Admin. Letter #2 approved

12/28/15

Initial IRB Approval =

10.13.2014 (site activated by

sponsor 4/28/15 )

Expires July 30, 2016

PROSPECTIVE OBSERVATIONAL STUDYOF PATIENTS

WITH POLYCYTHEMIA VERA IN US CLINICAL

PRACTICES (REVEAL)

Eligibility: PV diagnosis, receiving care including, not ltd to:

surveillance, ASA (> 81 mg), antithrombotic therapy, PHL-

phlebotomy, HU-hydroxyurea, interferon, busulfan, anagrelide; NO

2ndary AML, MDS, prior or planned stem cell transplant,

splenectomy

No intervention per protocol Observational clinical data collection

Questionnaires: baseline & Q 3 months x 3-4 yrs.

Optional blood sampling annually x 3-4 yrs.

EVA-17261-00

HN-4808 exp.

Pts = ________

NOTE: Open only at main

campus (EMCP)

IRB Approval expires 2/24/17

Qualitative Interviews in Patients with Hepatocellular

Carcinoma (HCC): Relevant Items from the Patient-Reported

Outcomes Version of the Common Terminology Criteria for

Adverse Events (PRO-CTCAE)

Eligibility: Confirmation (histologic or clinical) confirmation of

HCC; Child-Pugh A or B; ECOG PS 0-1; may be uninfected or

HBV, HCV positive. NO fibrolamellar or mixed cholangio-

carcinoma, active co-infection with Hep B & C; hepatitis other

than B or C; NO brain mets (known or suspected); NO prior

liver transplant; NO known anti-PD-1/PD-L-1 treatment;

Non-interventional protocol.

One-to-one interview (90 minutes) between study

sponsor and consenting subjects.

Q of L will include:

FACT-Hep

PRO-CTCAE

EQ-5D

25

Supportive Care – Continued

STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY Varenicline (Chantix) Study

Sponsor: Univ. of Penn

Study Contact @ AEMC:

Tracy Kane (215) 456-4709

Extended Duration Varenicline for Smoking among Cancer

Patients: A Clinical Trial

Eligible subjects will be males and females:

1. > 18 years old; self-report smoking, on average, > 5 cigarettes

(menthol and non-menthol)/ week, for the last 6 months.

2. Diagnosed w/cancer (all sites) within the past 5 years; if

diagnosed >5 years ago, diagnosis must be currently active.

3. Karnofsky Score of > 60 or ECOG PS < 2 within 6 months of

enrollment.

4. Able to use varenicline safely, based on a medical evaluation

including medical history and physical examination, and

psychiatric evaluation.

5. Residing in the geographic area for at least 12 months.

6. Women of childbearing potential (based on medical history and

physical exam) must consent to use a medically accepted method of

birth control (e.g., condoms and spermicide, oral contraceptive,

Depo-Provera injection, contraceptive patch, tubal ligation) or

abstain from sexual intercourse during the time they are taking

study medication and for at least one month after the medication

period ends.

7. Able to communicate fluently in English.

8. Capable of giving written informed consent, which includes

compliance with the requirements and restrictions listed in the

combined consent/HIPAA form

Chantix/Varenicline + counseling for 24 weeks versus

12 weeks

Wiser (lymphedema) Study

Sponsor: NCI/Penn

Study Contact @ Penn:

Renata Alford (215) 827-9549

The Women in Steady Exercise Research (WISER) study info

Eligibility Criteria: One year out breast cancer survivors with

lymphedema

The intervention focuses on the effects of

exercise and weight loss.

26

Multiple Cancer Diagnoses (Breast, Ovarian, & Colon)

CPTAC

Study Contacts:

Clinical Proteomics Tumor Analysis Consortium

Eligibility: Breast – page 8 of SOP

Colon – page 21 of SOP

Ovarian – page 26 of SOP

Pre-op blood and surgical tissue (see SOP)

27

Trials Pending Activation – none pending 3.21.16


28

DATE: October 24, 2014

SUBJECT: ECOG-ACRIN PCO Move

The ECOG Pathology Coordinating Office – Reference Laboratory (PCO) currently located at Northwestern University in Chicago is moving to the new ECOG-

ACRIN Central Biorepository and Pathology Facility (EA CBPF) at The University of Texas M.D. Anderson Cancer Center in Houston effective November 3,

2014. Please DO NOT send any specimens to the new location prior to the effective date.

Effective November 3, 2014, all samples originally intended for shipment to the PCO must be shipped to the new Central Biorepository and Pathology Facility

(EA CBPF) at the address below:

ECOG-ACRIN Central Biorepository and Pathology Facility

MD Anderson Cancer Center

Department of Pathology, Unit 085

Tissue Qualification Laboratory for ECOG-ACRIN, Room G1.3586

1515 Holcombe Blvd

Houston, TX 77030

Phone: Toll Free 1-844-744-2420 (713-745-4440 Local or International Sites)

Fax: 713-563-6506

Email: [email protected]

In order to assist sites, the Sample Tracking System shipment manifests will be updated with this information. Protocols will be updated on a rolling basis, but

please note that regardless of the protocol language all protocol shipments to the PCO must be sent instead to the EA CBPF at M.D. Anderson starting

November 3rd

.

Kit ordering and pre-paid FedEx (as applicable, per protocol) are unaffected by the move.

Shipments to any other banks or investigating laboratories are unaffected by the PCO-EA CBPF move.

While archived materials are in transit to the EA CBPF, shipping of materials to investigators will be processed on a case-by-case basis.

Please contact the ECOG-ACRIN translational science team at [email protected] or (617) 632-3610 with any questions.

mailto:[email protected]

mailto:[email protected]

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