Official Title: “A Phase 2, Randomized, Non-Comparative, Two-Arm Open Label, Multiple-Center Study Of CP-751,871 In Combination With Docetaxel/Prednisone In Chemotherapy- Naive (Arm A) And Docetaxel/Prednisone Refractory (Arm B) Patients With Hormone Insensitive Prostate Cancer”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

• Drug: CP-751,871
  • 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).
• Drug: docetaxel
  • Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
• Drug: prednisone
  • Prednisone is administered at a dose of 5 mg twice daily.
• Drug: docetaxel
  • Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
• Drug: prednisone
  • Prednisone is administered at a dose of 5 mg twice daily.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • 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.
• Active Comparator: B

Primary Measures

• PSA response
  • Time Frame: 3 months
    Safety Issue?: No
• Antitumor efficacy measured as Objective Responses using PSA Working Group and RECIST criteria.
  • Time Frame: 3 months
    Safety Issue?: No

Secondary Measures

• Safety and tolerability
  • Time Frame: 3 weeks
    Safety Issue?: Yes
• Safety,pharmacokinetics,pharmacodynamics of CP-751,871/docetaxel/prednisone
  • Time Frame: 3 weeks
    Safety Issue?: Yes
• progression-free survival
  • Time Frame: 3 months
    Safety Issue?: No
• Quality of Life Outcomes
  • Time Frame: 3 months
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

• Previous treatment with chemotherapy

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00313781

Study ID Number: A4021011

ClinicalTrials.gov Identifier: NCT00313781

Health Authority: United States: Food and Drug Administration

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