Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483782
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2007-06-06
Brief Title:
Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Newly Diagnosed Ovarian Epithelial Cancer Fallopian Tube Cancer or Primary Peritoneal Cavity Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
ICON7 - A Randomised Two-Arm Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy Carboplatin and Paclitaxel in Patients With Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2012-04
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 such as carboplatin and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or stopping them from dividing Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor It is not yet known whether giving carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer fallopian tube cancer or primary peritoneal cavity cancer
PURPOSE This randomized phase III trial is studying carboplatin paclitaxel and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer fallopian tube cancer or primary peritoneal cavity cancer
PURPOSE This randomized phase III trial is studying carboplatin paclitaxel and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer fallopian tube cancer or primary peritoneal cavity cancer
Detailed Description:
OBJECTIVES
Primary
Compare the progression-free survival and overall survival of patients with newly diagnosed ovarian epithelial fallopian tube or primary peritoneal cavity cancer treated with carboplatin and paclitaxel with vs without bevacizumab
Secondary
Compare the response rate in patients treated with these regimens
Compare the duration of tumor response in patients treated with these regimens
Compare the biological progression-free interval as measured by increasing CA 125 levels in patients treated with these regimens
Compare the safety eg adverse events laboratory results and performance status of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Compare the cost-effectiveness of these regimens in these patients
OUTLINE This is a multicenter open-label randomized controlled study Patients are stratified according to FIGO stage stage I-III with residual disease 1 cm vs stage I-III with residual disease 1 cm vs stage IV disease intended time to start chemotherapy after surgery 4 weeks vs 4 weeks and participating center Patients are randomized to 1 of 2 treatment arms
Arm I control Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive bevacizumab IV over 30-90 minutes followed by paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients then continue to receive bevacizumab alone every 3 weeks for 12 courses
Quality of life is assessed at baseline before every course every 6 weeks for 1 year every 3 months until disease progression or for up to 2 years and then at 3 years Health economic data is assessed periodically including days of inpatient hospitalization visits outpatient visits and use of anticancer therapies
After completion of study treatment patients are followed every 3-6 months for 5 years and then annually thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Primary
Compare the progression-free survival and overall survival of patients with newly diagnosed ovarian epithelial fallopian tube or primary peritoneal cavity cancer treated with carboplatin and paclitaxel with vs without bevacizumab
Secondary
Compare the response rate in patients treated with these regimens
Compare the duration of tumor response in patients treated with these regimens
Compare the biological progression-free interval as measured by increasing CA 125 levels in patients treated with these regimens
Compare the safety eg adverse events laboratory results and performance status of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Compare the cost-effectiveness of these regimens in these patients
OUTLINE This is a multicenter open-label randomized controlled study Patients are stratified according to FIGO stage stage I-III with residual disease 1 cm vs stage I-III with residual disease 1 cm vs stage IV disease intended time to start chemotherapy after surgery 4 weeks vs 4 weeks and participating center Patients are randomized to 1 of 2 treatment arms
Arm I control Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive bevacizumab IV over 30-90 minutes followed by paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients then continue to receive bevacizumab alone every 3 weeks for 12 courses
Quality of life is assessed at baseline before every course every 6 weeks for 1 year every 3 months until disease progression or for up to 2 years and then at 3 years Health economic data is assessed periodically including days of inpatient hospitalization visits outpatient visits and use of anticancer therapies
After completion of study treatment patients are followed every 3-6 months for 5 years and then annually thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MREC-06MRE0252 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000548777 | REGISTRY | None | None |
| EUDRACT-2005-003929-22 | None | None | None |
| ISRCTN91273375 | None | None | None |
| EU-20730 | None | None | None |
| ROCHE-MREC-ICON7 | None | None | None |