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A Phase II Trial Of Bevacizumab (NSC#704865) Plus Gemcitabine In Patients With Advanced Pancreatic Cancer

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

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Trial Information

A Phase II Trial Of Bevacizumab (NSC#704865) Plus Gemcitabine In Patients With Advanced Pancreatic Cancer


I. To determine the objective response rate of patients with advanced pancreatic cancer who
are treated with gemcitabine plus bevacizumab.

II. To determine the toxicity experienced by patients with advanced pancreatic cancer who
are treated with gemcitabine plus bevacizumab.

III. To determine median and overall survival of patients with advanced pancreatic cancer
who are treated with gemcitabine plus bevacizumab.


I. To measure plasma VEGF and serum VCAM-1 levels before, during, and after therapy as a
predictor of outcome.

II. To collect and store serum samples for possible future assessment of other
antiangiogenic inhibition markers.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over
30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease
progression or unacceptable toxicity.

Inclusion Criteria:

- Histologically or cytologically confirmed pancreatic adenocarcinoma

- Not amenable to curative treatment with surgery or radiotherapy

- Locally advanced disease must extend outside the boundaries of a standard
radiation port

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- Pleural effusions and ascites not considered measurable lesions

- No obvious tumor involvement of major vessels on CT scan

- No known brain metastases

- Performance status - ECOG 0-2

- More than 3 months

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- No prior bleeding diathesis

- Bilirubin normal

- AST/ALT no greater than 2.5 times upper limit of normal

- PT INR no greater than 1.5

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- Urine protein less than 500 mg/24 hours if at least 1+ proteinuria

- No significant renal impairment

- No prior cardiovascular accident

- No prior deep vein thrombosis

- No myocardial ischemia or infarction within the past 6 months

- No uncompensated coronary artery disease within the past 6 months

- No uncontrolled hypertension

- No symptomatic congestive heart failure

- No cardiac arrhythmia

- No clinically significant peripheral artery disease

- No arterial thromboembolic event within the past 6 months, including any of the

- Transient ischemic attack

- Cerebrovascular accident

- Unstable angina

- Myocardial infarction

- No prior pulmonary embolism

- No concurrent uncontrolled illness

- No ongoing or active infection

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

- No psychiatric illness or social situation that would preclude study entry

- No prior allergic reaction attributed to compounds of similar chemical or biologic
composition to bevacizumab or other agents (Chinese hamster ovary cell products or
other recombinant human antibodies) used in this study

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior bevacizumab

- No prior cytotoxic chemotherapy for metastatic disease

- No prior gemcitabine

- At least 4 weeks since prior adjuvant chemotherapy and recovered

- At least 4 weeks since prior radiotherapy and recovered

- No prior radiotherapy to sole site of measurable disease

- At least 6 weeks since prior major surgery

- At least 30 days since prior investigational agents

- At least 1 month since prior and no concurrent thrombolytic agents or full-dose
anticoagulants (except to maintain patency of pre-existing permanent indwelling IV

- No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal
anti-inflammatory drugs known to inhibit platelet function

- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent anticancer therapy

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (complete or partial responses)

Outcome Time Frame:

Up to 2 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:

February 2002

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Recurrent 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