Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005026
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2000-04-06
Brief Title:
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase I Feasibility Trial of Carboplatin and Topotecan Followed by Carboplatin and Paclitaxel Sequential Doublets in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2008-07
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the feasibility of administering multiple courses of carboplatin and topotecan without excessive dose modification or course delay in patients with previously untreated ovarian epithelial or primary peritoneal carcinoma II Describe the response rate and progression-free interval in these patients with this treatment regimen III Determine pharmacokinetic and pharmacodynamic parameters related to the sequence of carboplatin and topotecan administration in these patients
OUTLINE Patients are assigned to one of three treatment regimens Regimen I Patients receive carboplatin IV over 30 minutes on day 1 followed by topotecan IV over 30 minutes on days 1-3 Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Regimen II Patients receive topotecan IV over 30 minutes on days 1-3 followed by carboplatin IV over 30 minutes on day 3 Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Regimen III Patients receive topotecan IV over 30 minutes on days 1-5 followed by carboplatin IV over 30 minutes on day 5 Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 1 month and then every 3 months for 1 year
PROJECTED ACCRUAL A total of 15-80 patients will be accrued for this study within 2 years
OUTLINE Patients are assigned to one of three treatment regimens Regimen I Patients receive carboplatin IV over 30 minutes on day 1 followed by topotecan IV over 30 minutes on days 1-3 Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Regimen II Patients receive topotecan IV over 30 minutes on days 1-3 followed by carboplatin IV over 30 minutes on day 3 Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Regimen III Patients receive topotecan IV over 30 minutes on days 1-5 followed by carboplatin IV over 30 minutes on day 5 Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 1 month and then every 3 months for 1 year
PROJECTED ACCRUAL A total of 15-80 patients will be accrued for this study within 2 years
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-9906 | None | None | None |