Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003523
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2000-09-11
Brief Title:
Aminocamptothecin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Cancer of the Peritoneum
Sponsor:
Gynecologic Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Evaluation of Aminocamptothecin 9-AC NSC 603071 in Recurrent Platinum Resistant and Refractory Ovarian Cancer and Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2005-06
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 aminocamptothecin in treating patients with recurrent or refractory ovarian epithelial cancer or primary cancer of the peritoneum
PURPOSE Phase II trial to study the effectiveness of aminocamptothecin in treating patients with recurrent or refractory ovarian epithelial cancer or primary cancer of the peritoneum
Detailed Description:
OBJECTIVES I Estimate the antitumor activity of aminocamptothecin colloidal dispersion in patients with platinum-resistant recurrent or refractory ovarian cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols II Determine the nature and degree of toxicity of aminocamptothecin colloidal dispersion in this patient population
OUTLINE Patients receive aminocamptothecin colloidal dispersion IV over 120 hours weekly for two of every three weeks Courses are repeated every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 23-56 patients will be accrued for this study within 5-12 months
OUTLINE Patients receive aminocamptothecin colloidal dispersion IV over 120 hours weekly for two of every three weeks Courses are repeated every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 23-56 patients will be accrued for this study within 5-12 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-126I | None | None | None |