Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005836
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2000-06-02
Brief Title:
Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- Based Chemotherapy
Sponsor:
Gynecologic Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Evaluation of Oxaliplatin in Recurrent Platinum Resistant and Refractory Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2003-03
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 oxaliplatin in treating patients who have recurrent or refractory ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based chemotherapy
PURPOSE Phase II trial to study the effectiveness of oxaliplatin in treating patients who have recurrent or refractory ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based chemotherapy
Detailed Description:
OBJECTIVES I Determine the antitumor activity of oxaliplatin by measuring response rate in patients with recurrent or refractory platinum resistant ovarian epithelial or primary peritoneal carcinoma who have failed on higher priority treatment protocols II Determine the nature and degree of toxicity of this drug in this patient population
OUTLINE Patients receive oxaliplatin IV over 2 hours Treatment continues every 21 days for a maximum of 9 courses in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 22-60 patients will be accrued for this study within 12-14 months
OUTLINE Patients receive oxaliplatin IV over 2 hours Treatment continues every 21 days for a maximum of 9 courses in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 22-60 patients will be accrued for this study within 12-14 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-126K | None | None | None |