Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborators:
Genentech
Sanofi
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00361231
First received: August 4, 2006
Last updated: August 7, 2009
Last verified: August 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Biliary Tract Adenocarcinoma Gallbladder Adenocarcinoma |
Drug: Bevacizumab Drug: Gemcitabine Drug: Oxaliplatin |
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 Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Unresectable or Metastatic Biliary Tract and Gallbladder Cancer |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- To assess the progression free survival of GEMOX-B regimen in patients with unresectable or metastatic biliary tract and gallbladder adenocarcinoma. [ Time Frame: TBD ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the toxicities of the GEMOX-B regimen in this population of patients [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- to assess the response rate, the duration of response and median survival of GEMOX-B in this patient population [ Time Frame: TBD ] [ Designated as safety issue: No ]
- to evaluate changes on PET scans with treatment and correlation of PET scan change with PFS, response and OS. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 37 |
| Study Start Date: | May 2006 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
Drug: 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.
Drug: 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.
- 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361231
Sponsors and Collaborators
Massachusetts General Hospital
Genentech
Sanofi
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Investigators
| Principal Investigator: | Andrew X. Zhu, MD | Massachusetts General Hospital |
More Information
No publications provided by Massachusetts General Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Andrew Zhu, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00361231 History of Changes |
| Other Study ID Numbers: | 05-349 |
| Study First Received: | August 4, 2006 |
| Last Updated: | August 7, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
Avastin GEMOX |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Gallbladder Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Biliary Tract Neoplasms Digestive System Neoplasms Neoplasms by Site Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases Gemcitabine |
Oxaliplatin Bevacizumab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on June 13, 2013