Ro 31-7453 in Treating Patients With Recurrent or Refractory Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of Ro 31-7453 in treating patients who have recurrent or refractory metastatic colorectal cancer.
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Study of Two Shcedules of Ro 31-7453 in Patients With Metastatic (Dukes' D) Colorectal Carcinoma (CRC) Who Have Failed Both Fluoropyrimidine and Irinotecan Chemotherapy|
|Study Start Date:||December 2000|
|Study Completion Date:||June 2002|
|Primary Completion Date:||June 2002 (Final data collection date for primary outcome measure)|
- Compare the objective disease rate of patients with recurrent or refractory metastatic colorectal cancer treated with two dose schedules of Ro 31-7453.
- Compare the safety and tolerability of these regimens in these patients.
- Compare the response duration in patients treated with these regimens.
- Compare the time to progression and time to treatment failure in patients treated with these regimens.
- Determine the pharmacokinetic profiles of Ro 31-7453 and its major metabolites in these patients.
- Compare the overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral Ro 31-7453 twice daily on days 1-4. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral Ro 31-7453 twice daily on days 1-14. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 28 days and then every 3 months.
PROJECTED ACCRUAL: Approximately 160 patients (49 per treatment arm plus 61 additional patients in the arm determined to be most effective) will be accrued for this study within 1 year.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Sunil Sharma, MD||Memorial Sloan-Kettering Cancer Center|