NCT00657878

Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval

Liposomal Doxorubicin Versus Carboplatin/Paclitaxel in Patients With Ovarian Cancer Recurrence Between 6 and 12 Months After Previous Platinum Based Therapy: Phase III Randomized Multicenter Study Amendment Title Protocol Version 2.0: Phase III International Multicenter Randomized Study Testing the Effect on Survival of Prolonging Platinum-free Interval in Patients With Ovarian Cancer Recurring Between 6 and 12 Months After Previous Platinum Based Chemotherapy.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative.

Detailed description

Ovarian cancer is the most deadly gynecologic cancer. Though many patients respond well initially to chemotherapy, most of them in time will suffer a relapse. Patients often receive multiple lines of chemotherapy for their recurrences, and the choice of chemotherapy depends largely on the time interval since the last therapy. Patients whose disease recurs longer than 12 months after a platinum containing treatment are considered to be platinum sensitive, and are candidates for retreatment with a platinum regimen. Patients in whom disease recurs less than 6 months after a platinum containing treatment are considered platinum resistant or refractory, and are treated with a non platinum chemotherapy. The option of treatment is less clear for patients whose disease recurs between 6 and 12 months after platinum containing therapy. It is hypothesized that prolonging the interval since last platinum treatment by using a non platinum chemotherapy will result in better outcomes for these patients. This study will evaluate if the experimental sequence of a non platinum based chemotherapy, followed at a later progression by a platinum based chemotherapy is superior, in terms of the effect on overall survival, to the standard inverse sequence of treatment.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	stealth liposomal doxorubicin	stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days
DRUG	carboplatin	carboplatin AUC 5 IV day 1 every 21 days
DRUG	paclitaxel	paclitaxel 175 mg/m2 IV day 1 every 21 days
DRUG	Topotecan	dosing and schedule according to Institutional guidelines
DRUG	Gemcitabine	1000 mg/m2 on days 1,8,15 every 28 days

Timeline

• Start date: 2008-11-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2008-04-14
• Last updated: 2023-11-13

Locations

40 sites across 3 countries: Belgium, Germany, Italy