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

NCT00361231 | Completed Phase 2 Results DMC

• 1 other identifier: 05-349
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Biliary Tract Cancer; Gallbladder Adenocarcinoma

Keywords

Avastin; GEMOX

Outcome Measures

Primary Outcomes (1)

• Median Progression Free Survival

  To assess the median progression free survival in patients with BTC on GEMOX-B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition, death in the absence of radiological disease progression was also categorized as progression.

  2 years

Secondary Outcomes (1)

• Overall Response Rate

  2 years

Study Arms (1)

Bevacizumab, Gemcitabine, Oxaliplatin

EXPERIMENTAL

* 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. * 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.

Drug: Bevacizumab; Drug: Gemcitabine; Drug: Oxaliplatin

Interventions

Bevacizumab DRUG

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.

Also known as: Avastin

Bevacizumab, Gemcitabine, Oxaliplatin

Gemcitabine DRUG

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.

Also known as: Gemzar

Bevacizumab, Gemcitabine, Oxaliplatin

Oxaliplatin DRUG

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.

Also known as: Eloxatin

Bevacizumab, Gemcitabine, Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Genentech, Inc.: collaborator
• Sanofi: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (2)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• 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.

  PMID: 25794066 DERIVED

• 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.

  PMID: 19932054 DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Bevacizumab; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Dr. Andrew X. Zhu
• Organization: Massachusetts General Hospital

azhu@mgh.harvard.edu

617-724-4000

Study Officials

• Andrew X. Zhu, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2006
• First Posted: August 8, 2006
• Study Start: May 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: August 1, 2012
• Last Updated: February 7, 2017
• Results First Posted: February 7, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)