Conditions: Prostatic Neoplasms
Keywords: randomized non-comparative efficacy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 204
Healthy volunteers: no

Brief summary:
To test the efficacy of CP-751,871 combined with docetaxel and prednisone in the treatment of prostate cancer that is refractory to hormone therapy

Detailed description:

Arms:
arm 1: For patients treated with docetaxel and prednisone only, who progress during treatment, CP-751,871 will be added to the regimen to test reversibility of chemoresistance. arm 2: None

Interventions: intervention 1: CP-751,871 intervention 2: docetaxel intervention 3: prednisone intervention 4: docetaxel intervention 5: prednisone
Intervention descriptions: intervention 1: CP-750,871 is administered intravenously at a dose of 20 mg/kg on day 1 of each 21-day cycle (for patient convenience and logistical management, the dose of CP-751,871 may be deferred up to 7 days). intervention 2: Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2. intervention 3: Prednisone is administered at a dose of 5 mg twice daily. intervention 4: Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2. intervention 5: Prednisone is administered at a dose of 5 mg twice daily.

Protocol document: