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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Genentech
Sanofi-Synthelabo
Hoffmann-La Roche
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00142480
First received: August 31, 2005
Last updated: December 28, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Biliary Tract Cancer
Gallbladder Adenocarcinoma
Drug: Capecitabine
Drug: Oxaliplatin
Drug: Bevacizumab
Procedure: Radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Biliary Tract and Gallbladder Cancer

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To determine the progression free survival rate at one year for locally advanced, or resected with positive margins, biliary tract and gallbladder cancer patients [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety of the combination capecitabine, oxaliplatin, bevacizumab in patients with biliary tract and gallbladder cancer [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: December 2004
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Capecitabine
    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).
    Drug: Oxaliplatin
    Given intravenously once weekly during weeks 1, 2, 4 and 5 on days 1, 8, 22 and 29
    Drug: Bevacizumab
    Given intravenously every two weeks during weeks 1, 3 and 5 on days 1, 15 and 29.
    Procedure: Radiation therapy
    Once daily for 5 days (Monday through Friday) for a total of 28 treatments.
Detailed Description:

There are two phases of study treatment. The first phase is for all patients and will last about 6 weeks. During this phase, oxaliplatin will be given intravenously once a week during weeks 1, 2, 4, and 5 on days 1, 8, 22, and 29; bevacizumab will be given intravenously once every 2 weeks during weeks 1, 3, and 5 on days 1, 15, and 29; capecitabine will be administered orally for 14 consecutive days (days 1-14), then a week of no capecitabine, followed by another 14 days of capecitabine (days 22-35).

Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments.

During this first phase of the study the following tests will be performed weekly: physical exam, vital signs, medical history, blood tests and urine tests.

After the first phase is finished patients will wait 4 weeks then have a CT scan, MRCP, blood tests and a physical exam to evaluate the status of the disease.

Phase two of the study is broken up into two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease.

If the patients had tumors removed prior to entering the study, they will be treated again with all 3 study drugs but no radiation over a 6-week period as they did earlier in the study. This 6-week regimen will be repeated twice for a total of 12 weeks of treatment.

Patients with advanced disease that could not be removed by surgery when they first entered the study but the evaluation tests after the first phase show the tumor has responded (reduced in size) and can now be resected, will have surgery to remove the tumors.

Following surgical recovery (8-10 weeks) they will be treated again with all 3 of the study drugs but no radiation over a 6-week period as they did earlier in the study. This 6-week regimen will be repeated twice for a total of 12 weeks of study treatment.

If the evaluation tests show that the patients' cancer has remained stable (not gotten worse or better) they will be treated again with all three study drugs but no radiation over a 6-week period as they did earlier in the study. This 6-week regimen will be repeated twice for a total of 12 weeks of study treatment.

During the additional 12 weeks of study treatment a physical exam, vital signs, medical history, blood testing and urine testing will be performed once every 3 weeks.

At the end of study treatment the following evaluations will be performed: physical exam, vital signs, blood work, CT scan of the chest and abdomen, MRCP, and tumor measurements by CT scans. These evaluations will be repeated every 3 months thereafter.

Patients will be removed from the study if their disease worsens or there are unacceptable side effects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 18 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
  • Creatinine clearance > 50 ml/min

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142480

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Genentech
Sanofi-Synthelabo
Hoffmann-La Roche
Investigators
Principal Investigator: Andrew Zhu, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Andrew Zhu, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00142480     History of Changes
Other Study ID Numbers: 04-144
Study First Received: August 31, 2005
Last Updated: December 28, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
locally advanced biliary adenocarcinoma
unresectable biliary adenocarcinoma
gallbladder adenocarcinoma
capecitabine
oxaliplatin
bevacizumab
Biliary tract adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Biliary Tract Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Bevacizumab
Capecitabine
Oxaliplatin
Fluorouracil
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 16, 2014