Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-28 @ 9:54 PM
Study NCT ID:
NCT00016250
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ro 31-7453 in Treating Patients With Recurrent or Refractory Metastatic Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
OBJECTIVES:
* 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.
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: