Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016250
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-05-06
Brief Title:
Ro 31-7453 in Treating Patients With Recurrent or Refractory Metastatic Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-1945 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068613 | REGISTRY | None | None |
| ROCHE-16113 | None | None | None |
| ROCHE-RO31-7453 | None | None | None |