Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003821
Status:
WITHDRAWN
Last Update Posted:
2018-09-18
First Post:
1999-11-01
Brief Title:
Aminopterin in Treating Patients With Recurrent or Refractory Endometrial Cancer
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Phase II Trial of Aminopterin in Patients With Persistent or Recurrent Endometrial Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2000-07
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 aminopterin in treating patients who have refractory or recurrent endometrial cancer
PURPOSE Phase II trial to study the effectiveness of aminopterin in treating patients who have refractory or recurrent endometrial cancer
Detailed Description:
OBJECTIVES I Estimate the antitumor activity of aminopterin in patients with persistent recurrent or refractory endometrial carcinoma who have failed prior first line cytotoxic chemotherapy II Determine the quantitative and qualitative toxic effects of aminopterin in this patient population III Determine the overall patient survival and time to progression of these patients IV Assess the pharmacokinetic profile of these patients
OUTLINE Patients receive oral aminopterin every 12 hours twice weekly Treatment continues for up to 15 months in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study
OUTLINE Patients receive oral aminopterin every 12 hours twice weekly Treatment continues for up to 15 months in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 15-25 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 |
|---|---|---|---|
| NCI-V99-1531 | None | None | None |
| ILEX-AMT221-A1 | None | None | None |
| ILEX-AMT221 | None | None | None |