Phase 2 N=35 Treatment

Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer

Biliary Tract Cancer · Gallbladder Adenocarcinoma

Bottom Line

View on ClinicalTrials.gov: NCT00361231 ↗

Enrolled (actual)

Serious AEs

34.3%

Results posted

Feb 2017

Primary outcome: Primary: Median Progression Free Survival — 7.0 months — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bevacizumab (Drug); Gemcitabine (Drug); Oxaliplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Progression Free Survival	7.0	<0.05 sig
SECONDARY Overall Response Rate	—	0.05

Summary

The purposes of this study are to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good and bad) this combination has on patients with cancer of bile duct or gallbladder. Bevacizumab has been shown to slow or stop cell growth in tumors by decreasing the blood supply to the tumors.

Eligibility Criteria

Inclusion Criteria

Histologically confirmed, locally unresectable or metastatic biliary tract or gallbladder adenocarcinoma. Patients must have at least one measurable lesion outside prior radiation field.
Zero to one prior chemotherapy for biliary tract or gallbladder cancer
Age > 18 years
ECOG performance status 0-2
Life expectancy > 12 weeks
Adequate organ and bone marrow function

Exclusion Criteria

Chemotherapy within past 3 weeks of initiation of therapy
Pregnant or lactating women
Clinically apparent central nervous system metastases or carcinomatous meningitis
Biliary obstruction with inadequate drainage and total bilirubin > 2.5 mg/dL
Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Uncontrolled serious medical or psychiatric illness
Pre-existing peripheral neuropathy of grade 2 or greater severity according to the Common Terminology Criteria of the NCI (version 3.0)
Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
Blood pressure of > 150/100 mmHg
Unstable angina
NYHA Grade II or greater congestive heart failure
History of myocardial infarction or stroke within 6 months
Clinically significant peripheral vascular disease
Evidence of bleeding diathesis or coagulopathy
Major surgical procedure, open biopsy, or significant traumatic injury with 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1
Serious, non-healing wound, ulcer, or bone fracture

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00361231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.