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A Randomized Phase II Study of Bevacizumab (NSC# 704865) and Gemcitabine in Combination With Either Cetuximab (NSC# 714692) or OSI-774 (NSC# 718781) in Patients With Advanced Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

A Randomized Phase II Study of Bevacizumab (NSC# 704865) and Gemcitabine in Combination With Either Cetuximab (NSC# 714692) or OSI-774 (NSC# 718781) in Patients With Advanced Pancreatic Cancer


I. Compare the objective response rate in patients with advanced adenocarcinoma of the
pancreas treated with bevacizumab and gemcitabine with cetuximab vs erlotinib.

II. Compare the toxicity of these regimens in these patients. III. Compare median
progression-free and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center (University of Chicago vs other) and ECOG performance status (0-1 vs
2). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV
over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and

Arm II: Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral
erlotinib once daily on days 1-5, 8-12, and 15-26.

In both arms, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 54-126 patients (27-63 per treatment arm) will be accrued for
this study within 16 months.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the pancreas

- Advanced disease

- Patients with locally advanced disease must have disease that extends
outside the boundaries of a standard radiation port

- Not amenable to curative surgery or radiotherapy

- Measurable disease

- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
OR ≥ 10 mm by spiral CT scan

- Pleural effusions and ascites are not considered measurable lesions

- No CNS disease, including primary brain tumors or brain metastasis

- No tumor invasion into the duodenum

- Performance status - ECOG 0-2

- More than 3 months

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- WBC ≥ 3,000/mm^3

- No history of bleeding diatheses

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT and SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)

- INR ≤ 1.5 (≤ 3 for patients on warfarin)

- No esophageal varices

- Creatinine ≤ 1.5 mg/dL

- Creatinine clearance ≥ 60 mL/min

- Urine protein < 1+

- 24-hour urine protein < 500 mg

- No history of a recent cerebrovascular accident

- No clinically significant cardiovascular disease

- No uncontrolled hypertension

- No New York Heart Association class II-IV congestive heart failure

- No serious cardiac arrhythmia requiring medication

- No peripheral vascular disease ≥ grade II

- None of the following arterial thromboembolic events within the past 6 months:

- Transient ischemic attack

- Cerebrovascular accident

- Unstable angina

- Myocardial infarction

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 3 months
after study participation

- HIV negative

- No significant traumatic injury within the past 28 days

- No gastrointestinal tract disease resulting in an inability to take oral medication

- No allergic reactions to compounds similar to bevacizumab, cetuximab, or erlotinib
(e.g., Chinese hamster ovary cell products or recombinant humanized antibodies)

- No serious or non-healing wound, ulcer, or bone fracture

- No active infection requiring antibiotics

- No other active malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No prior bevacizumab or cetuximab

- No other prior vascular endothelial growth factor inhibitors

- No prior gemcitabine

- No prior cytotoxic chemotherapy for metastatic disease

- At least 4 weeks since prior adjuvant chemotherapy (6 weeks for mitomycin or

- At least 4 weeks since prior radiotherapy

- Must have a site of measurable disease outside the radiation port

- No prior surgical procedure affecting absorption

- More than 28 days since prior major surgical procedure or open biopsy

- More than 7 days since prior core biopsy

- No concurrent major surgical procedures

- No prior erlotinib

- No other prior epidermal growth factor receptor inhibitors

- At least 30 days since prior investigational drugs

- More than 1 month since prior thrombolytic agents

- Concurrent warfarin or low molecular weight heparin allowed provided the following
criteria are met:

- Currently therapeutic on a stable dose

- INR target range ≤ 3

- Patients undergo weekly INR testing

- No evidence of active bleeding or pathological condition that carries high risk
of bleeding (e.g., tumor invading adjacent organs or esophageal varices)

- No concurrent chronic daily therapy with aspirin (> 325 mg/day) or nonsteroidal
anti-inflammatory medications known to inhibit platelet function

- No other concurrent antiplatelet medications

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent anticancer therapies or agents

- No other concurrent investigational drugs

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (complete or partial response) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

Up to 7 years

Safety Issue:


Principal Investigator

Hedy Kindler

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2004

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage II Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470