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Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer

NCT00417976 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-10-01

Study results available
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Summary

This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients' response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure response.

Conditions

Interventions

DRUG

Gemcitabine

1000 mg/m2 over 100 minutes every 2 weeks.

DRUG

Bevacizumab

10 mg/kg every 2 weeks.

DRUG

Infusional 5-Fluorouracil

2400 mg/m2 over 48 hours every 2 weeks.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Tony Bekaii-Saab

    lead OTHER

Principal Investigators

  • Tanios Saab, M.D. · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-03-31
Completion
2011-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00417976 on ClinicalTrials.gov