Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096187
Status:
TERMINATED
Last Update Posted:
2018-04-12
First Post:
2004-11-09
Brief Title:
Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Trial of Pemetrexed ALIMTA LY231514 IND 40061 as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor
Status:
TERMINATED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as pemetrexed disodium work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent low-risk gestational trophoblastic tumor after a molar pregnancy
PURPOSE This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent low-risk gestational trophoblastic tumor after a molar pregnancy
Detailed Description:
OBJECTIVES
Determine the activity of pemetrexed disodium as salvage therapy in patients with persistent or recurrent low-risk post-molar gestational trophoblastic tumor that failed prior dactinomycin or methotrexate
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive pemetrexed disodium IV over 10 minutes on day 1 Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression or until tumor marker levels human chorionic gonadotropin hCG become normal Patients receive 2 additional courses beyond the attainment of a normal hCG
Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium patients also receive oral folic acid daily and cyanocobalamin vitamin B_12 intramuscularly every 9 weeks
Patients are followed every 2 weeks for 2 months and then monthly for 10 months
PROJECTED ACCRUAL Approximately 17-55 patients will be accrued for this study within 20-50 months
Determine the activity of pemetrexed disodium as salvage therapy in patients with persistent or recurrent low-risk post-molar gestational trophoblastic tumor that failed prior dactinomycin or methotrexate
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive pemetrexed disodium IV over 10 minutes on day 1 Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression or until tumor marker levels human chorionic gonadotropin hCG become normal Patients receive 2 additional courses beyond the attainment of a normal hCG
Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium patients also receive oral folic acid daily and cyanocobalamin vitamin B_12 intramuscularly every 9 weeks
Patients are followed every 2 weeks for 2 months and then monthly for 10 months
PROJECTED ACCRUAL Approximately 17-55 patients will be accrued for this study within 20-50 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 |
|---|---|---|---|
| GOG-0217 | None | None | None |
| GOG-UC0205 | None | None | None |
| LILLY-H3E-US-JMGR | None | None | None |