Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006453
Status:
COMPLETED
Last Update Posted:
2015-12-23
First Post:
2000-11-06
Brief Title:
Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy
Sponsor:
AGO Study Group
Organization:
AGO Study Group
Study Overview
Official Title:
A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy
Status:
COMPLETED
Status Verified Date:
2015-12
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 It is not yet known if carboplatin is more effective with or without gemcitabine for ovarian epithelial cancer
PURPOSE Randomized phase III trial to compare the effectiveness of carboplatin with or without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has not responded to previous chemotherapy
PURPOSE Randomized phase III trial to compare the effectiveness of carboplatin with or without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES
Compare time to progression in patients with advanced ovarian epithelial carcinoma who failed prior first-line platinum-based therapy when treated with carboplatin with or without gemcitabine
Compare response rate duration of response and survival time of patients treated with these regimens
Compare the toxicity of these treatment regimens in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to progression-free time 6-12 months vs more than 12 months type of prior first-line therapy and bidimensionally measurable disease yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive carboplatin IV over 30-60 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8
Arm II Patients receive carboplatin IV as in arm I Treatment in both arms repeats every 3 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each subsequent chemotherapy course and at 50 days after study
Patients are followed at 50 days every 2 months for 1 year and then every 3 months for 1 year
PROJECTED ACCRUAL A total of 350 patients will be accrued for this study
Compare time to progression in patients with advanced ovarian epithelial carcinoma who failed prior first-line platinum-based therapy when treated with carboplatin with or without gemcitabine
Compare response rate duration of response and survival time of patients treated with these regimens
Compare the toxicity of these treatment regimens in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to progression-free time 6-12 months vs more than 12 months type of prior first-line therapy and bidimensionally measurable disease yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive carboplatin IV over 30-60 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8
Arm II Patients receive carboplatin IV as in arm I Treatment in both arms repeats every 3 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each subsequent chemotherapy course and at 50 days after study
Patients are followed at 50 days every 2 months for 1 year and then every 3 months for 1 year
PROJECTED ACCRUAL A total of 350 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-V00-1601 | None | None | None |
| AGOSG-OVAR-25 | None | None | None |
| CAN-NCIC-OV15 | None | None | None |
| EORTC-55005 | None | None | None |
| EU-20064 | None | None | None |