Gemcitabine And Bevacizumab In Treating Patients With Pancreatic Cancer That Has Been Completely Removed By Surgery

Study Overview

Gemcitabine and Bevacizumab in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By Surgery

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine and bevacizumab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I/II trial is studying the side effects of gemcitabine and bevacizumab and to see how well they work in treating patients with pancreatic cancer that has been completely removed by surgery.

OBJECTIVES: Primary * Determine the safety of adjuvant, fixed-dose rate gemcitabine hydrochloride and bevacizumab in patients with completely resected pancreatic cancer. * Determine the 1-year disease-free survival rate in patients treated with this regimen. Secondary * Determine the 1- and 2-year overall survival rates in these patients. * Determine the median disease-free survival rate in these patients. * Determine the median overall survival rate in these patients. OUTLINE: This is an open-label, non-randomized study. Patients receive gemcitabine hydrochloride IV over 100 minutes followed by bevacizumab* IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease recurrence or unacceptable toxicity. NOTE: *The first dose of bevacizumab is not administered until after 6 weeks have passed since surgery. After completion of study therapy, patients are followed periodically for 18 months. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Pancreatic Cancer

BIOLOGICAL: bevacizumab
DRUG: gemcitabine hydrochloride
PROCEDURE: adjuvant therapy

CDR0000517330
UCSF-06451
UCSF-H12191-28980-01

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 2006-12-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-09-13
First Submitted that Met QC Criteria 2006-12-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-09-17
First Posted (ESTIMATED) 2006-12-13	Results First Posted N/A	Last Verified 2012-09

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:
Non Randomized

Interventional Model:
N/A

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Safety of gemcitabine when administered with bevacizumab as assessed by NCI CTCAE v3.0
Disease-free survival rate at 1 year

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival rate at 1 and 2 years
Median disease-free survival rate at 1 and 2 years
Median overall survival rate at 1 and 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 adenocarcinoma of the pancreas

Completely resected disease

Underwent 1 of the following procedures 3-8 weeks ago:

Standard pancreaticoduodenectomy (for tumors of the pancreatic head)
Distal pancreatectomy (for tumors of the pancreatic tail)
No grossly positive surgical margins

Positive microscopic margins allowed
Nonmeasurable disease
No known CNS disease

ECOG performance status 0-1
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after completion of study therapy
CA 19-9 ≤ 2.5 times upper limit of normal (ULN)
Absolute neutrophil count ≥ 1,500/mm³
Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)
Platelet count ≥ 100,000/mm³
INR ≤ 1.5 (except in patients receiving full-dose warfarin)
Bilirubin ≤ 2.0 mg/dL
AST and ALT ≤ 2.5 times ULN
Creatinine ≤ 2.0 mg/dL
No clinically significant impairment of renal function
No postoperative complications, including any of the following:

Wound dehiscence or infection
Intra-abdominal abscess
Pancreatic or biliary leak or fistula
Grade 3 or 4 delayed hemorrhage (occurring > 5 days postoperatively)
Bowel perforation
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abcess within the past 6 months
No history of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates use of the study drugs or renders the patient at high risk of treatment-related complications
No other cancer within the past 5 years except basal cell or squamous cell skin cancer
No history of serious systemic disease, including any of the following:

Myocardial infarction or unstable angina within the past 12 months
New York Heart Association class II-IV congestive heart failure
Unstable symptomatic arrhythmia requiring medication

Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
No history of stroke or transient ischemic attack
No symptomatic peripheral vascular disease
No significant vascular disease (e.g., aortic aneurysm, aortic dissection)
No inadequately controlled hypertension (i.e., blood pressure > 150/100 mm Hg on antihypertensive medication)
No prior hypertensive crisis or hypertensive encephalopathy
No proteinuria (defined as urine protein:creatinine ratio ≥ 1.0 OR proteinuria ≥ 2+ by dipstick urinalysis OR protein > 1 g by 24-hour urine collection)
No serious, nonhealing wound or ulcer
No evidence of bleeding diathesis or coagulopathy
No significant traumatic injury within the past 28 days

See Disease Characteristics
No prior chemotherapy or radiotherapy for pancreatic cancer
No prior systemic or investigational therapy for pancreatic cancer
No major surgical procedure (except for resection of pancreatic cancer) or open biopsy within the past 28 days
No fine-needle aspiration or core biopsy within the past 7 days
No anticipated need for a major surgical procedure during study treatment
No concurrent newly prescribed nonsteroidal anti-inflammatory drugs (NSAIDs)

Concurrent chronic-dose NSAIDs for analgesia are allowed

Collaborators and Investigators

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

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Andrew Ko, MD, University of California, San Francisco

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

Learn

Resources

Patients

Caregivers

Clinical Trial Record