A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT00881504
Phase
PHASE2
Status
Terminated

Conditions

  • Biliary Tract Cancer

Eligibility Criteria

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

Interventions

  • "Bevacizumab" in combination with "modified FOLFOX6". — DRUG
    Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay \> 4 weeks

Study Details

This study is for patients with biliary tract cancer that has spread and who are not candidates for surgical resection. The purpose of this research is to determine if bevacizumab can be safely administered with Modified FOLFOX 6 and find out what effects, good and/or bad, this type of treatment has on biliary cancer. In this study, a combination of chemotherapy, Modified FOLFOX6 and a biologic agent, bevacizumab will be tested. Subjects on this study will receive chemotherapy and bevacizumab every 2 weeks until their disease gets worse or they are unable to tolerate treatment.

Key Dates

First listed
Apr 15, 2009
Start date
Jun 30, 2009
Status verified
Sep 2014
Primary completion
Feb 28, 2011
Completion
Dec 31, 2011

Study Design

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

Arms

  • Experimental: "FOLFOX6" and "Bevacizumab"
    Intervention = "bevacizumab" in combination with chemotherapy Treatment of biliary system carcinoma using "Bevacizumab" in combination with "modified FOLFOX6".

Primary Outcome Measure

Progression-free Survival [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Georgetown University Medical CenterWashington D.C.District of Columbia20007-

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Georgetown University Medical Center· Washington D.C., DC

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