Gemcitabine Hydrochloride With Or Without Bevacizumab In Treating Patients Who Are Undergoing Surgery For Pancreatic Cancer

Study Overview

Gemcitabine Hydrochloride With or Without Bevacizumab in Treating Patients Who Are Undergoing Surgery for Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, 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 an 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 hydrochloride together with bevacizumab after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying gemcitabine hydrochloride and bevacizumab to see how well they work compared to gemcitabine hydrochloride alone in treating patients who are undergoing surgery for pancreatic cancer.

OBJECTIVES: Primary * Compare the disease-free interval in patients with adenocarcinoma of the pancreas treated with surgical resection followed by adjuvant gemcitabine hydrochloride with vs without bevacizumab. Secondary * Compare overall survival in patients treated with these regimens. * Evaluate tumor gene expression profiles and levels of tumor angiogenesis markers to establish prognostic indicators for response in patients treated with these regimens. OUTLINE: This is a randomized, controlled study. All patients undergo surgical resection for the pancreatic tumor. Within 4-8 weeks after surgery, patients are stratified according to projected 2-year survival (≤ 5% vs > 5% and ≤ 33% vs > 33%). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses. Patients then receive bevacizumab IV alone every 2 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.

Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage I Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer

DRUG: bevacizumab
DRUG: gemcitabine hydrochloride
PROCEDURE: adjuvant therapy
PROCEDURE: anti-cytokine therapy
PROCEDURE: antiangiogenesis therapy
PROCEDURE: antibody therapy
PROCEDURE: biological therapy
PROCEDURE: chemotherapy
PROCEDURE: conventional surgery
PROCEDURE: growth factor antagonist therapy
PROCEDURE: monoclonal antibody therapy
PROCEDURE: surgery

CDR0000448825
NCI-05-C-0158
NCI-P6503

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 2005-11-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-04-27
First Submitted that Met QC Criteria 2005-11-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-04-28
First Posted (ESTIMATED) 2005-11-15	Results First Posted N/A	Last Verified 2006-12

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:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

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
No evidence of distant metastasis on laparoscopy
No superior mesenteric artery or thrombosed superior mesenteric vein involvement
Superior mesenteric vein or portal vein involvement allowed
Evidence of a pancreatic mass by radiographic or endoscopic examination

ECOG 0-1

Not specified

WBC ≥ 2,500/mm^3
Absolute neutrophil count ≥ 1,250/mm^3
Platelet count ≥ 100,000/mm^3

Hepatitis B surface antigen negative
Hepatitis C virus negative
No history of hepatic cirrhosis

Creatinine ≤ 2.0 mg/dL
Proteinuria negative or trace by urinalysis OR
Protein < 1 g on 24 hr urine collection
No active gross hematuria

No severe congestive heart failure
No active ischemic heart disease
No ischemic changes on a cardiac thallium stress test
No uncontrolled hypertension (i.e., blood pressure ≤ 150/100 mm Hg despite antihypertensive therapy)
No active coagulation disorder

No active gross hemoptysis

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during the adjuvant therapy part of trial
HIV negative
No active infection
No wound healing problem from recent invasive procedure
No significant history of medical illness that would preclude patient from undergoing an operative procedure
No other malignancy requiring systemic therapy

Recovered from prior immunotherapy for pancreatic cancer
No prior bevacizumab

Recovered from prior chemotherapy for pancreatic cancer
No prior gemcitabine hydrochloride

Recovered from prior hormonal therapy for pancreatic cancer

Recovered from prior radiotherapy for pancreatic cancer
No prior radiotherapy to the pancreas

No prior definitive resection of the primary pancreatic tumor
Prior surgery, other than resection of the primary tumor, allowed

More than 3 weeks since prior systemic therapy for this cancer
No concurrent therapeutic anticoagulation causing elevated PT or PTT

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Richard E. Royal, MD, FACS, National Cancer Institute (NCI)

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