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MITO-2: Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Ovarian Cancer
NCT00326456Phase 3
Key facts
- Status
- Unknown
- Start
- Jan 2003
- Primary completion
- Dec 2023
- Countries
- 3
- Sponsor
- National Cancer Institute
- Modality
- Targeted Liposomes, Stealth (PEGylated) Liposomes, Conventional Liposomes
- Conditions
- ovarian cancer
01
Overview
Phase 3, randomised, open-label trial of pegylated liposomal doxorubicin in ovarian cancer (2 arms), sponsored by National Cancer Institute. Primary endpoint: Progression Free Survival at 2 years. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Carboplatin + Liposomal Doxorubicin
Carboplatin AUC 5 and Liposomal Doxorubicin 30 mg/m2 every 3 weeks for 6 cycles
Carboplatin + Paclitaxel
Carboplatin AUC 5 and Paclitaxel 175 mg/m2 every 3 weeks for 6 cycles
03
Who it enrols
Patients with stage Ic-IV ovarian cancer, age <= 75, ECOG <= 2, no prior chemotherapy, and adequate organ function.
04
Endpoints
Primary
Progression Free Survival
Secondary
Overall Survival
Quality of Life
Objective Response Rate
Adverse Events
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