Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI UCCRC-11255B NCI-2675, 2675, NCT00028834

Objectives

1. Determine the objective response rate of patients with advanced pancreatic cancer treated with bevacizumab and gemcitabine.
2. Determine the toxicity of this regimen in these patients.
3. Determine the median and overall survival of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• No prior bevacizumab

Chemotherapy:

• No prior cytotoxic chemotherapy for metastatic disease
• No prior gemcitabine
• At least 4 weeks since prior adjuvant chemotherapy and recovered

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered
• No prior radiotherapy to sole site of measurable disease

Surgery:

• See Disease Characteristics
• At least 6 weeks since prior major surgery

Other:

• 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 catheters)
• 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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• No prior bleeding diathesis

Hepatic:

• Bilirubin normal
• AST/ALT no greater than 2.5 times upper limit of normal
• PT INR no greater than 1.5

Renal:

• Creatinine no greater than 1.5 mg/dL

  OR

• Creatinine clearance at least 60 mL/min
• Urine protein less than 500 mg/24 hours if at least 1+ proteinuria
• No significant renal impairment

Cardiovascular:

• 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 following:
  • Transient ischemic attack
  • Cerebrovascular accident
  • Unstable angina
  • Myocardial infarction

Pulmonary:

• No prior pulmonary embolism

Other:

• 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

Expected Enrollment

A total of 21-50 patients will be accrued for this study within 8-10 months.

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.

Kindler HL, Friberg G, Singh DA, et al.: Phase II trial of bevacizumab plus gemcitabine in patients with advanced pancreatic cancer. J Clin Oncol 23 (31): 8033-40, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Hedy Kindler, MD, Protocol chair		Ph: 773-702-0360; 888-824-0200

Registry Information
Official Title		A Phase II Trial Of Bevacizumab (NSC#704865) Plus Gemcitabine In Patients With Advanced Pancreatic Cancer
Trial Start Date		2002-02-20
Registered in ClinicalTrials.gov		NCT00028834
Date Submitted to PDQ		2001-11-09
Information Last Verified		2004-10-12
NCI Grant/Contract Number		N01-CM17102, P30-CA14599

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