Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Newly Diagnosed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
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|ClinicalTrials.gov Identifier: NCT00483782|
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Biological: bevacizumab Drug: carboplatin Drug: paclitaxel Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: quality-of-life assessment||Phase 3|
- 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.
- 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 (e.g., 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1520 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2006|
- Progression-free survival
- Duration of overall survival
- Objective response rate
- Duration of response
- Biological progression-free interval as measured by increasing CA 125 levels
- Safety as measured by NCI CTAE version 3.0
- Quality of life
- Health economics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483782
|Study Chair:||Tim J. Perren, MD||Leeds Cancer Centre at St. James's University Hospital|