Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00006015
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying combination chemotherapy plus trastuzumab to see how well it works in treating patients with advanced, recurrent, or metastatic colorectal cancer.
- Detailed Description
OBJECTIVES:
* Determine the response rate of patients who overexpress HER-2/neu with metastatic colorectal adenocarcinoma who have progressed on at least 1 prior, but no more than 2 prior, chemotherapy regimens for metastatic colorectal cancer treated with fluorouracil, leucovorin calcium, oxaliplatin, and trastuzumab (Herceptin).
* Determine the time to progression of these patients treated with this regimen.
* Determine the overall toxicity of this regimen in these patients.
OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22, followed by oxaliplatin IV over 2 hours on days 1 and 15, and then followed by leucovorin calcium IV over 2 hours on days 1, 8, and 15. Fluorouracil IV is administered at the midpoint of the leucovorin calcium infusion on days 1, 8, and 15. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combination Chemotx trastuzumab Combination chemotherapy for metastatic colorectal cancer in patients who have disease progression after 5-FU and/or irinotecan-containing therapy Combination Chemotx leucovorin calcium Combination chemotherapy for metastatic colorectal cancer in patients who have disease progression after 5-FU and/or irinotecan-containing therapy Combination Chemotx fluorouracil Combination chemotherapy for metastatic colorectal cancer in patients who have disease progression after 5-FU and/or irinotecan-containing therapy Combination Chemotx oxaliplatin Combination chemotherapy for metastatic colorectal cancer in patients who have disease progression after 5-FU and/or irinotecan-containing therapy
- Primary Outcome Measures
Name Time Method Response rate Every 2 tx cycles Time to progression Every 2 tx cycles Overall toxicity Each cycle during tx
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Scroll for more (37 remaining)Veterans Affairs Medical Center - Birmingham🇺🇸Birmingham, Alabama, United States