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DOXIL vs DaunoXome in AIDS-Related Kaposi's Sarcoma
NCT00002985Phase 3
Key facts
- Status
- Completed
- Start
- Nov 1996
- Primary completion
- Jan 2007
- Countries
- 1
- Modality
- DNA Intercalators/Alkylators
- Drugs
- doxorubicin
- Conditions
- Kaposi's sarcoma (KS)
01
Overview
Phase 3, randomised, double-blind trial of doxorubicin in Kaposi's sarcoma (KS) (2 arms), sponsored by Roswell Park Comprehensive Cancer Center. Primary endpoint: Clinical benefit compared to baseline status at 12 weeks. Started Nov 1996; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Doxil
doxorubicin HCl liposome (Doxil) given every 2 weeks for 6 courses by intravenous infusion over 60 minutes
DaunoXome
daunorubicin (DaunoXome) given every 2 weeks for 6 courses by intravenous infusion over 60 minutes
03
Who it enrols
Patients with AIDS-related Kaposi's sarcoma requiring systemic chemotherapy, with adequate hematologic, hepatic, and cardiac function, and no other active malignancies.
04
Endpoints
Primary
Clinical benefit compared to baseline status
Secondary
Tumor response
Safety of Doxil
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