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
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 (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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
No
Tim J. Perren, MD
Study Chair
Leeds Cancer Centre at St. James's University Hospital
Unspecified
CDR0000548777
NCT00483782
April 2006
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