Bortezomib, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Stomach Cancer
- Conditions
- Gastric Cancer
- Registration Number
- NCT00103103
- Lead Sponsor
- California Cancer Consortium
- Brief Summary
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with fluorouracil and leucovorin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with fluorouracil and leucovorin works in treating patients with metastatic or unresectable stomach cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine response in patients with previously treated metastatic or unresectable gastric or gastroesophageal junction adenocarcinoma treated with bortezomib, fluorouracil, and leucovorin calcium.
Secondary
* Determine time to progression and overall survival of patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a non-randomized, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. One hour after completion of bortezomib, patients receive leucovorin calcium IV and fluorouracil IV followed by fluorouracil IV continuously over 46 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for survival.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate as measured by RECIST every 8 weeks
- Secondary Outcome Measures
Name Time Method Time to progression every 8 weeks Overall survival Toxicity every 4 weeks Molecular correlates on and off study treatment
Trial Locations
- Locations (5)
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
City of Hope Medical Group
🇺🇸Pasadena, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States