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

Biliary Tract Cancer Clinical Trial

Official title:

Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Unresectable or Metastatic Biliary Tract and Gallbladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361231
• Other study ID #: 05-349
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2006
• Last updated: March 15, 2014
• Start date: May 2006
• Est. completion date: August 2012

Study information

• Verified date: March 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2012
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Gallbladder Adenocarcinoma

Intervention

Drug:
• Bevacizumab
Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
• Gemcitabine
Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
• Oxaliplatin
Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Genentech, Inc., Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median progression free survival	To assess the median progression free survival in patients with BTC on GEMOX-B.	2 years	No
Secondary	Number of patients experiencing Adverse Events	To evaluate the tolerability and toxicities of GEMOX-B in this population of patients.	2 years	Yes
Secondary	Overall response rate	To assess the overall response rate of GEMOX-B in patients with advanced BTC.	2 years	No
Secondary	Changes in SUVmax for RECIST response, progression free survival, and overall survival	To assess changes in SUVmax from PET scans for RECIST response, progression free survival, and overall survival in patients receiving GEMOX-B for advanced BTC.	2 years	No