Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer

NCT00142480 | Completed Phase 2 DMC

• 1 other identifier: 04-144
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

The main purpose of this study is to test the safety and effectiveness of oxaliplatin, bevacizumab, and capecitabine given in combination with radiation therapy to see what effects (good or bad) they have on patients with biliary tract and gallbladder cancer.

Conditions

Biliary Tract Cancer; Gallbladder Adenocarcinoma

Keywords

locally advanced biliary adenocarcinoma; unresectable biliary adenocarcinoma; gallbladder adenocarcinoma; capecitabine; oxaliplatin; bevacizumab; Biliary tract adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• To determine the progression free survival rate at one year for locally advanced, or resected with positive margins, biliary tract and gallbladder cancer patients

  3 years

Secondary Outcomes (1)

• To evaluate the safety of the combination capecitabine, oxaliplatin, bevacizumab in patients with biliary tract and gallbladder cancer

  3 years

Study Arms (1)

Capecitabine, Oxaliplatin, Bevacizumab

EXPERIMENTAL

There are two phases of study treatment. Phase I includes all patients and will last 6 weeks. During this phase, oxaliplatin will be given intravenously (IV) on days 1, 8, 22, and 29; bevacizumab will be given IV on days 1, 15, and 29; capecitabine will be administered orally on days 1-14 and 22-35. Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments. Phase II has two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease. Patients who had their tumors removed prior to entering the study will be treated with the above 6-week regimen twice for a total of 12 weeks of treatment. Patients who were unresectable prior to entering the study but then were deemed resectable after treatment on trial will undergo resection. Following surgical recovery (8-10 weeks) they will be treated again with the above 6-week regimen twice for a total of 12 weeks of treatment.

Drug: Capecitabine; Drug: Oxaliplatin; Drug: Bevacizumab; Procedure: Radiation therapy

Interventions

Capecitabine DRUG

Given orally for 14 consecutive days (days 1-14) followed by a week of no capecitabine then another week of 14 consecutive days (days 21-28).

Capecitabine, Oxaliplatin, Bevacizumab

Oxaliplatin DRUG

Given intravenously once weekly during weeks 1, 2, 4 and 5 on days 1, 8, 22 and 29

Capecitabine, Oxaliplatin, Bevacizumab

Bevacizumab DRUG

Given intravenously every two weeks during weeks 1, 3 and 5 on days 1, 15 and 29.

Capecitabine, Oxaliplatin, Bevacizumab

Radiation therapy PROCEDURE

Once daily for 5 days (Monday through Friday) for a total of 28 treatments.

Capecitabine, Oxaliplatin, Bevacizumab

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 advanced unresectable biliary tract or gallbladder adenocarcinoma
• Patients with resected biliary tract or gallbladder adenocarcinoma who have residual tumor left will also be eligible.
• \> 4 weeks since time of major surgery
• \> 2 weeks since time of minor surgery
• \> 4 weeks since time of major radiotherapy for other malignancy
• \> 4 weeks since participation in any investigational drug study
• \> 1 year since treatment for other carcinomas, except cured non-melanoma skin and treated in-situ cervical cancer
• years of age or older
• ECOG performance status of 0-2
• Life expectancy \> 12 weeks
• Absolute neutrophil count (ANC) \> 1,500/mm3
• Hemoglobin \> 9.0 gm/dl
• Platelets \> 100,000/mm3
• SGOT \< 5 x upper limits of normal (ULN)
• Total bilirubin \< 2.5 mg/dl

You may not qualify if:

• Prior chemotherapy or radiation therapy for biliary tract or gallbladder cancer
• Peripheral neuropathy of grade 2 or greater
• Unstable angina
• Symptomatic congestive heart failure
• Myocardial infarction \< 12 months prior to registration
• New York Heart Association classification III or IV
• Active or uncontrolled infection
• Known existing uncontrolled coagulopathy
• Malabsorption syndrome or lack of integrity of the upper gastrointestinal (GI) tract
• Prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency
• Known brain metastases or carcinomatous meningitis
• Pregnant or lactating women
• Serious, non-healing wound, ulcer, or bone fracture
• Evidence of bleeding diathesis or coagulopathy

Sponsors & Collaborators

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

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Capecitabine; Oxaliplatin; Bevacizumab; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Andrew Zhu, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

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 31, 2005
• First Posted: September 2, 2005
• Study Start: December 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: April 1, 2011
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

US (3)