Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005030
Status:
WITHDRAWN
Last Update Posted:
2018-11-14
First Post:
2000-04-06
Brief Title:
SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase IB Study of Oral Administration of SCH 66336 Preoperatively in Patients With Colorectal Carcinoma Metastatic to the Liver Scheduled for Exploratory Laparotomy andor Resection
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No enrollment
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 I trial to compare the effectiveness of different doses of SCH 66336 before surgery in treating patients who have colorectal cancer that has metastasized to the liver
PURPOSE Randomized phase I trial to compare the effectiveness of different doses of SCH 66336 before surgery in treating patients who have colorectal cancer that has metastasized to the liver
Detailed Description:
OBJECTIVES I Determine the biologic activity and safety of preoperative SCH 66336 in patients with colorectal carcinoma metastatic to the liver
OUTLINE This is a randomized multicenter study Patients are randomized to one of four doses of preoperative SCH 66336 no treatment 100 mg 200 mg or 300 mg Patients receive oral SCH 66336 twice daily for 7-14 days prior to exploratory laparotomy andor resection of hepatic metastases Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization Other patients undergo surgery on days 8-15
PROJECTED ACCRUAL A total of 40 patients 10 per arm will be accrued for this study within 10 months
OUTLINE This is a randomized multicenter study Patients are randomized to one of four doses of preoperative SCH 66336 no treatment 100 mg 200 mg or 300 mg Patients receive oral SCH 66336 twice daily for 7-14 days prior to exploratory laparotomy andor resection of hepatic metastases Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization Other patients undergo surgery on days 8-15
PROJECTED ACCRUAL A total of 40 patients 10 per arm will be accrued for this study within 10 months
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 |
|---|---|---|---|
| ID99-229 | OTHER | UT MD Anderson Cancer Center | None |
| MDA-ID-99229 | None | None | None |
| SPRI-C98-546 | None | None | None |
| NCI-G00-1713 | None | None | None |