Clinical trial NCT00361231: Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer
Official title: Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Unresectable or Metastatic Biliary Tract and Gallbladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biliary Tract Cancer
Gallbladder Adenocarcinoma
Keywords: Avastin
GEMOX
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Sanofi
name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: Dana-Farber Cancer Institute
First posted: 2006-08-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: * The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
* Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
* The following tests and procedures will be performed on day 1 and day 15 or each cycle: physical examination; medical history; blood work; and urine test. A PET scan will be repeated at the end of cycle 2 and CT scans will be repeated once every 8 weeks.
* Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.

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

Primary outcomes:
measure: Median Progression Free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall Response Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Andrew X. Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sahani DV, Hayano K, Galluzzo A, Zhu AX. Measuring treatment response to systemic therapy and predicting outcome in biliary tract cancer: comparing tumor size, volume, density, and metabolism. AJR Am J Roentgenol. 2015 Apr;204(4):776-81. doi: 10.2214/AJR.14.13223.
citation: Zhu AX, Meyerhardt JA, Blaszkowsky LS, Kambadakone AR, Muzikansky A, Zheng H, Clark JW, Abrams TA, Chan JA, Enzinger PC, Bhargava P, Kwak EL, Allen JN, Jain SR, Stuart K, Horgan K, Sheehan S, Fuchs CS, Ryan DP, Sahani DV. Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: a phase 2 study. Lancet Oncol. 2010 Jan;11(1):48-54. doi: 10.1016/S1470-2045(09)70333-X. Epub 2009 Nov 20.