Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087087
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
2004-07-08
Brief Title:
Pemetrexed Disodium in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation Of Pemetrexed ALIMTA LY231514 IND 40061 In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-02
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 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 ovarian epithelial cancer or primary peritoneal cancer
PURPOSE This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Determine the antitumor activity of pemetrexed disodium in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer that failed higher priority treatment protocols
Determine the nature and degree of 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 disease progression or unacceptable toxicity
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 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 19-51 patients will be accrued for this study within 11-22 months
Determine the antitumor activity of pemetrexed disodium in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer that failed higher priority treatment protocols
Determine the nature and degree of 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 disease progression or unacceptable toxicity
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 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 19-51 patients will be accrued for this study within 11-22 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 |
|---|---|---|---|
| CDR0000372919 | None | None | None |
| LILLY-H3E-US-JMGP | None | None | None |