Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)
To test the efficacy of CP-751,871 combined with docetaxel and prednisone in the treatment of prostate cancer that is refractory to hormone...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: April 2011
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
Outcome Measures for this Clinical Trial
Primary Measures
- PSA response
- Time Frame: 3 months
Safety Issue?: No
- Time Frame: 3 months
- Antitumor efficacy measured as Objective Responses using PSA Working Group and RECIST criteria.
- Time Frame: 3 months
Safety Issue?: No
- Time Frame: 3 months
Secondary Measures
- Safety and tolerability
- Time Frame: 3 weeks
Safety Issue?: Yes
- Time Frame: 3 weeks
- Safety,pharmacokinetics,pharmacodynamics of CP-751,871/docetaxel/prednisone
- Time Frame: 3 weeks
Safety Issue?: Yes
- Time Frame: 3 weeks
- progression-free survival
- Time Frame: 3 months
Safety Issue?: No
- Time Frame: 3 months
- Quality of Life Outcomes
- Time Frame: 3 months
Safety Issue?: No
- Time Frame: 3 months
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Pfizer Industry
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00313781
