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
- 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
- Determine the pharmacokinetic profiles of Ro 31-7453 and its major metabolites in these
- 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
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Sunil Sharma, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|