Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer
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.
Drug: leucovorin calcium
|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 Evaluating the Combination of 5-Fluorouracil, Leucovorin, Oxaliplatin, and Herceptin in the Treatment of Patients With Metastatic Colorectal Cancer Who Have Progressed After 5-FU and/or Irinotecan-Containing Therapy|
- Response rate [ Time Frame: Every 2 tx cycles ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Every 2 tx cycles ] [ Designated as safety issue: No ]
- Overall toxicity [ Time Frame: Each cycle during tx ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2000|
|Study Completion Date:||February 2003|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
Experimental: Combination Chemotx
Combination chemotherapy for metastatic colorectal cancer in patients who have disease progression after 5-FU and/or irinotecan-containing therapy
4 mg/kg IV infusion Day 1, then weekly 2 mg/kg IV infusion (on Days 8, 15, & 22)
Other Name: HerceptinDrug: fluorouracil
500 mg/sq m IV push weekly for 3 weeks, followed by a 1 wk break
Other Name: 5-FUDrug: leucovorin calcium
500 mg/sq m IV infusion over 2 hours weekly for 3 weeks, then a 1 wk breakDrug: oxaliplatin
85 mg/sq m IV infusion over 2 hours Days 1 & 15 of each cycle
- 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.