Bevacizumab And Gemcitabine In Treating Patients With Advanced Pancreatic Cancer

Study Overview

Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer

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

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.

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

DRUG: gemcitabine hydrochloride
BIOLOGICAL: bevacizumab
OTHER: laboratory biomarker analysis

NCI-2012-02440
11255B
N01CM17102 (U.S. NIH Grant/Contract)
CDR0000069138 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2002-01-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-01-23
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-01-24
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2013-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment (gemcitabine hydrochloride, bevacizumab) 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.	DRUG: gemcitabine hydrochloride Given IV BIOLOGICAL: bevacizumab Given IV OTHER: laboratory biomarker analysis Correlative studies

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment (gemcitabine hydrochloride, bevacizumab)

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.

DRUG: gemcitabine hydrochloride

Given IV

BIOLOGICAL: bevacizumab

Given IV

OTHER: laboratory biomarker analysis

Correlative studies

Primary Outcome Measures	Measure Description	Time Frame
Objective response rate (complete or partial responses)		Up to 2 years

Secondary Outcome Measures	Measure Description	Time Frame
Progression-free survival	Calculated using the Kaplan-Meier method, and the median progression-free survival times and the associated 95% confidence intervals derived.	Up to 2 years
Overall survival	Calculated using the Kaplan-Meier method, and the median overall survival times and the associated 95% confidence intervals derived.	Up to 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Hedy Kindler, University of Chicago Comprehensive Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record