Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006267
Status:
WITHDRAWN
Last Update Posted:
2013-07-09
First Post:
2000-09-11
Brief Title:
Nitrocamptothecin in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation Of 9-Nitro-Camptothecin In The Third-Line Treatment Of Recurrent Ovarian Or Primary Peritoneal Cancer
Status:
WITHDRAWN
Status Verified Date:
2004-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Never activated
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 recurrent or metastatic ovarian epithelial or primary peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have recurrent or metastatic ovarian epithelial or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Determine the antitumor activity of nitrocamptothecin in patients with recurrent or metastatic ovarian epithelial or primary peritoneal cancer
Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE Patients receive oral nitrocamptothecin on days 1-5 Treatment continues every 7 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 2 weeks then every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 19-51 patients will be accrued for this study within 22 months
Determine the antitumor activity of nitrocamptothecin in patients with recurrent or metastatic ovarian epithelial or primary peritoneal cancer
Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE Patients receive oral nitrocamptothecin on days 1-5 Treatment continues every 7 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 2 weeks then every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 19-51 patients will be accrued for this study within 22 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-0186B | None | None | None |