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Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer

Primary Purpose

Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage III Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
bevacizumab
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 following: 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 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

Sites / Locations

  • University of Chicago Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (gemcitabine hydrochloride, bevacizumab)

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate (complete or partial responses)

Secondary Outcome Measures

Progression-free survival
Calculated using the Kaplan-Meier method, and the median progression-free survival times and the associated 95% confidence intervals derived.
Overall survival
Calculated using the Kaplan-Meier method, and the median overall survival times and the associated 95% confidence intervals derived.

Full Information

First Posted
January 4, 2002
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00028834
Brief Title
Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer
Official Title
A Phase II Trial Of Bevacizumab (NSC#704865) Plus Gemcitabine In Patients With Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase II trial is to see if combining gemcitabine with bevacizumab works in treating patients who have advanced pancreatic cancer. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells
Detailed Description
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (gemcitabine hydrochloride, bevacizumab)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Other Intervention Name(s)
dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Objective response rate (complete or partial responses)
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Calculated using the Kaplan-Meier method, and the median progression-free survival times and the associated 95% confidence intervals derived.
Time Frame
Up to 2 years
Title
Overall survival
Description
Calculated using the Kaplan-Meier method, and the median overall survival times and the associated 95% confidence intervals derived.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 following: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hedy Kindler
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States

12. IPD Sharing Statement

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Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer

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