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IV Paclitaxel/Cisplatin vs IV Paclitaxel + IP Cisplatin/Paclitaxel in Stage III Ovarian or Primary Peritoneal Cancer
NCT00003322Phase 3
Key facts
- Status
- Completed
- Start
- Mar 1998
- Primary completion
- Jan 2006
- Countries
- 2
- Sponsor
- GOG Foundation
- Modality
- Small Molecules
- Drugs
- paclitaxelcisplatin
- Conditions
- ovarian cancerprimary peritoneal carcinoma (PPC)
01
Overview
Phase 3, randomised, open-label trial of paclitaxel and cisplatin in ovarian cancer and primary peritoneal carcinoma (PPC) (2 arms), sponsored by GOG Foundation. Primary endpoints: Pathological response, Recurrence-free interval and 1 more. Started Mar 1998; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
IV Paclitaxel + IV Cisplatin
IV paclitaxel by 24-hour infusion on day 1 followed by IV cisplatin on day 2.
IV Paclitaxel + IP Cisplatin + IP Paclitaxel
IV paclitaxel by 24-hour infusion on day 1 followed by IP cisplatin on day 2, plus IP paclitaxel on day 8.
03
Who it enrols
Female patients with optimal stage III epithelial ovarian carcinoma or primary peritoneal carcinoma, GOG performance status 0-2, adequate organ function, and no prior chemotherapy or radiotherapy.
04
Endpoints
Primary
Pathological response
Recurrence-free interval
Overall Survival
Secondary
Toxic effects and complications
Quality of Life
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