Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005085
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2000-04-06
Brief Title:
Rebeccamycin Analog in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Rebeccamycin Analogue NSC 655649 in Patients With Metastatic Colorectal Cancer IMT Codes 23988 23989 23993
Status:
COMPLETED
Status Verified Date:
2002-12
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:
Phase II trial to study the effectiveness of rebeccamycin analog in treating patients who have metastatic or locally recurrent colorectal cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the objective response rate of patients with metastatic or locally recurrent colorectal cancer treated with rebeccamycin analogue
II Determine the toxicity of this regimen in this patient population III Determine the effect of this regimen on progression-free and overall survival in these patients
OUTLINE This is a multicenter study
Patients receive rebeccamycin analogue IV once on day 1 Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I Determine the objective response rate of patients with metastatic or locally recurrent colorectal cancer treated with rebeccamycin analogue
II Determine the toxicity of this regimen in this patient population III Determine the effect of this regimen on progression-free and overall survival in these patients
OUTLINE This is a multicenter study
Patients receive rebeccamycin analogue IV once on day 1 Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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-T99-0109 | None | None | None |
| AECM-T99-0109 | None | None | None |