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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Tony Bekaii-Saab
Study ID
NCT00417976
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    1000 mg/m2 over 100 minutes every 2 weeks.
  • Bevacizumab — DRUG
    10 mg/kg every 2 weeks.
  • Infusional 5-Fluorouracil — DRUG
    2400 mg/m2 over 48 hours every 2 weeks.

Study Details

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.

Key Dates

First listed
Jan 4, 2007
Start date
Dec 31, 2006
Status verified
Sep 2015
Primary completion
Mar 31, 2010
Completion
Feb 28, 2011

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab

Primary Outcome Measure

Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy [ Time Frame: 6 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
The University of MichiganAnn ArborMichigan48109-
The Ohio State University James Cancer HospitalColumbusOhio43210-

Find similar trials in Ann Arbor, MI

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
The University of Michigan· Ann Arbor, MIThe Ohio State University James Cancer Hospital· Columbus, OH

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