Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Prostatic Neoplasms

Treatments: Drug: CP-751,871; Drug: docetaxel; Drug: prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00313781

A4021011

Details and patient eligibility

About

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

Enrollment: 204 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of metastatic, progressive hormone refractory prostate cancer
• Adequate bone marrow, liver and kidney function

Exclusion criteria

• Previous treatment with chemotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

A

Experimental group

Description:

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.

Treatment:

Drug: docetaxel

Drug: prednisone

Drug: prednisone

Drug: docetaxel

Drug: CP-751,871

B

Active Comparator group

Treatment:

Drug: docetaxel

Drug: prednisone

Drug: prednisone

Drug: docetaxel