Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028743
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2002-01-04
Brief Title:
Combination Chemotherapy Regimens in Ovarian Epithelial Cancer Primary Peritoneal Cancer or Fallopian Tube Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Study of Cisplatin Plus Topotecan Followed by Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Women With Newly Diagnosed Advanced Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2020-03
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 and giving the drugs in different combinations may kill more tumor cells It is not yet known which combination chemotherapy regimen is more effective in treating ovarian epithelial primary peritoneal or fallopian tube cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIB stage III or stage IV ovarian epithelial cancer primary peritoneal cancer or fallopian tube cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIB stage III or stage IV ovarian epithelial cancer primary peritoneal cancer or fallopian tube cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of cisplatin and topotecan followed by paclitaxel and carboplatin vs paclitaxel and carboplatin only in terms of time to disease progression in patients with newly diagnosed stage IIB-IV ovarian epithelial primary peritoneal or fallopian tube cancer
Compare the overall survival of patients treated with these regimens
Compare the clinical objective response rates in patients with measurable disease at baseline treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the CA 125 normalization rates in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center age 65 years and under vs over 65 years and pre-randomization surgery no debulking vs debulking with macroscopic residual disease less than 1 cm vs debulking with macroscopic residual disease 1 cm or greater vs debulking with no macroscopic residual disease Patients are randomized to one of two treatment arms
Arm I Patients receive cisplatin IV over 60 minutes on day 1 and topotecan IV over 30 minutes on days 1-5 of courses 1-4 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 5-8
Arm II Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 1-8
In both arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Planned interval debulking surgery should occur after course 3 or 4
Quality of life is assessed at baseline on day 1 of courses 3 5 and 7 at the end of the last course and at 3 and 6 months after study treatment completion
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients 400 per treatment arm will be accrued for this study within 2 years
Compare the efficacy of cisplatin and topotecan followed by paclitaxel and carboplatin vs paclitaxel and carboplatin only in terms of time to disease progression in patients with newly diagnosed stage IIB-IV ovarian epithelial primary peritoneal or fallopian tube cancer
Compare the overall survival of patients treated with these regimens
Compare the clinical objective response rates in patients with measurable disease at baseline treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the CA 125 normalization rates in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center age 65 years and under vs over 65 years and pre-randomization surgery no debulking vs debulking with macroscopic residual disease less than 1 cm vs debulking with macroscopic residual disease 1 cm or greater vs debulking with no macroscopic residual disease Patients are randomized to one of two treatment arms
Arm I Patients receive cisplatin IV over 60 minutes on day 1 and topotecan IV over 30 minutes on days 1-5 of courses 1-4 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 5-8
Arm II Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 1-8
In both arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Planned interval debulking surgery should occur after course 3 or 4
Quality of life is assessed at baseline on day 1 of courses 3 5 and 7 at the end of the last course and at 3 and 6 months after study treatment completion
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients 400 per treatment arm will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000069129 | OTHER | PDQ | None |
| CAN-NCIC-OV16 | OTHER | None | None |
| EORTC-55012 | OTHER | None | None |
| GEICO-0101 | OTHER | None | None |