Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005877
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2000-06-02
Brief Title:
Nitrocamptothecin in Treating Patients With Advanced or Recurrent Colorectal Cancer
Sponsor:
Astex Pharmaceuticals Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II and Pharmacokinetic Study of RFS 2000 9-Nitro-Camptothecin 9-NC in Patients With Advanced Colorectal Cancer Who Have Failed Previous 5-FU Based Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2002-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced or recurrent colorectal cancer
PURPOSE Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced or recurrent colorectal cancer
Detailed Description:
OBJECTIVES I Determine the objective response rate overall survival and time to disease progression after maximal response in patients with advanced or metastatic colorectal cancer treated with oral nitrocamptothecin II Determine the safety toxicity and pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter study Patients receive oral nitrocamptothecin on days 1-5 Treatment repeats every week for 8 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease after completion of course 8 may receive additional courses Patients are followed every 3 months for 1 year or until death
PROJECTED ACCRUAL Approximately 14-45 patients will be accrued for this study over less than 1 year
OUTLINE This is a multicenter study Patients receive oral nitrocamptothecin on days 1-5 Treatment repeats every week for 8 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease after completion of course 8 may receive additional courses Patients are followed every 3 months for 1 year or until death
PROJECTED ACCRUAL Approximately 14-45 patients will be accrued for this study over less than 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 |
|---|---|---|---|
| PCI-99-037 | None | None | None |
| SUPERGEN-RFS2000-18 | None | None | None |