{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Temsirolimus 15 mg/m^2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Temsirolimus 20 mg/m^2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Temsirolimus 27 mg/m^2"}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"}],"units":"Participants"}],"description":"Dose limiting toxicities in each dose cohort.","groups":[{"description":"Single arm consists of temsirolimus (Torisel) plus liposomal doxorubicin (Doxil). Temsirolimus is administered IV in sequentially escalating cohorts at doses between 15 and 50 mg/M2 (body surface area), once weekly. Liposomal doxorubicin is administered IV at 30 mg per M2 (body surface area) once every 28 days. Treatment may continue with both drugs for 2 years. Temsirolimus may continue beyond 2 years.\n\ntemsirolimus plus liposomal doxorubicin: Patients will be treated with temsirolimus (Torisel) temsirolimus weekly by iv and with liposomal doxorubicin (Doxil) (standard dose) by iv once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until maximally tolerated dose (MTD) is reached. Once MTD (standard dose) is achieved, dosing will be with standard doses for each drug, but dosing will be modified based on toxicity.","id":"OG000","title":"Number of Subjects Who Experienced Dose-Limiting Toxicities"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"End of second 28-day cycle","title":"Part 1: Incidence of Dose Limiting Toxicities","type":"PRIMARY","unitOfMeasure":"participants"}