Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005873
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2000-06-02
Brief Title:
Nitrocamptothecin in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
Sponsor:
Astex Pharmaceuticals Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of RFS 2000 9-Nitro-Camptothecin 9-NC in Patients With Relapsed Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2001-09
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 Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have locally recurrent or metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have locally recurrent or metastatic breast cancer
Detailed Description:
OBJECTIVES I Assess the toxicity and efficacy of nitrocamptothecin in patients with locally recurrent or metastatic breast cancer II Determine the duration of response and time to treatment failure in these patients with this treatment regimen III Correlate serum levels of nitrocamptothecin and its lactone metabolite with response and toxicity in these patients IV Correlate topoisomerase I and II levels with toxicity and response in these patients
OUTLINE Patients receive oral nitrocamptothecin daily on days 1-5 Treatment continues weekly for 8 weeks Patients achieving complete or partial response or stable disease continue therapy in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-43 patients will be accrued for this study within 8-18 months
OUTLINE Patients receive oral nitrocamptothecin daily on days 1-5 Treatment continues weekly for 8 weeks Patients achieving complete or partial response or stable disease continue therapy in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-43 patients will be accrued for this study within 8-18 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 |
|---|---|---|---|
| SUPERGEN-RFS2000-17 | None | None | None |
| IUMC-9906-11 | None | None | None |