Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003378
Status:
TERMINATED
Last Update Posted:
2013-07-09
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Previously Untreated Stage III or Stage IV Ovarian or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase I Feasibility Trial of Carboplatin Paclitaxel and Gemcitabine in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal Carcinoma
Status:
TERMINATED
Status Verified Date:
2011-12
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 with previously untreated stage III or stage IV ovarian or primary peritoneal cancer
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy in treating patients with previously untreated stage III or stage IV ovarian or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the feasibility of administering multiple courses of chemotherapy without excessive dose modification or treatment delay in patients with previously untreated ovarian epithelial carcinoma or primary peritoneal carcinoma II Determine the response rate in patients with measurable disease and progression-free interval in these patients receiving this treatment
OUTLINE This is a feasibility study On day 1 patients receive paclitaxel as a 3 hour continuous IV infusion followed by carboplatin as a 30 minute infusion Gemcitabine is administered by continuous infusion over 30 minutes on day 1 following carboplatin and on day 8 In the absence of disease progression or unacceptable toxicity courses repeat every 21 days for a maximum of 8 courses Patients are followed every 3 months for 2 years every 6 months for the next 3 years and annually thereafter
PROJECTED ACCRUAL A total of 15-45 patients will be accrued for this study within approximately 2 years
OUTLINE This is a feasibility study On day 1 patients receive paclitaxel as a 3 hour continuous IV infusion followed by carboplatin as a 30 minute infusion Gemcitabine is administered by continuous infusion over 30 minutes on day 1 following carboplatin and on day 8 In the absence of disease progression or unacceptable toxicity courses repeat every 21 days for a maximum of 8 courses Patients are followed every 3 months for 2 years every 6 months for the next 3 years and annually thereafter
PROJECTED ACCRUAL A total of 15-45 patients will be accrued for this study within approximately 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-9801 | None | None | None |