Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005876
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2000-06-02
Brief Title:
Nitrocamptothecin in Treating Patients With Locally Advanced or Metastatic Stomach Cancer That Cannot Be Removed During Surgery
Sponsor:
Astex Pharmaceuticals Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of RFS 2000 Rubitecan 9-Nitro-Camptothecin 9-NC in Patients With Advanced Gastric Carcinoma
Status:
UNKNOWN
Status Verified Date:
2002-06
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 locally advanced or metastatic stomach cancer that cannot be removed during surgery
PURPOSE Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have locally advanced or metastatic stomach cancer that cannot be removed during surgery
Detailed Description:
OBJECTIVES I Determine the objective response rate progression-free survival overall survival and time to treatment failure in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with oral nitrocamptothecin II Determine the toxicity of this regimen in these patients
OUTLINE Patients are stratified according to prior therapy yes vs no 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 week 8 may receive additional courses of therapy Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 21-55 patients will be accrued for this study
OUTLINE Patients are stratified according to prior therapy yes vs no 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 week 8 may receive additional courses of therapy Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 21-55 patients will be accrued for this study
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 |
|---|---|---|---|
| MDA-DM-99231 | None | None | None |
| SUPERGEN-RFS2000-30 | None | None | None |