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

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00313781

Purpose

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

Condition	Intervention	Phase
Prostatic Neoplasms	Drug: CP-751,871 Drug: docetaxel Drug: prednisone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Docetaxel

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

PSA response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Antitumor efficacy measured as Objective Responses using PSA Working Group and RECIST criteria. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Safety,pharmacokinetics,pharmacodynamics of CP-751,871/docetaxel/prednisone [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
progression-free survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Quality of Life Outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	204
Study Start Date:	May 2006
Study Completion Date:	December 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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.
Active Comparator: B	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Previous treatment with chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313781

Locations

United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90048
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10032
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195-0001
Pfizer Investigational Site
Orange Village, Ohio, United States, 44122
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111-2497
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2L 4M1
Pfizer Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Germany
Pfizer Investigational Site
Berlin, Germany, 12200
Pfizer Investigational Site
Muenchen, Germany, 81675
Spain
Pfizer Investigational Site
Hospitalet de Llobregat, Barcelona, Spain, 08907
Pfizer Investigational Site
A Coruña, Spain, 15006
Pfizer Investigational Site
Barcelona, Spain, 08035
Switzerland
Pfizer Investigational Site
St. Gallen, Switzerland, CH-9007
United Kingdom
Pfizer Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Pfizer Investigational Site
Glasgow, United Kingdom, G12 0YH
Pfizer Investigational Site
Glasgow, United Kingdom, G52 3NQ
Pfizer Investigational Site
Guildford, United Kingdom, GU2 7WG

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00313781 History of Changes
Other Study ID Numbers:	A4021011
Study First Received:	April 10, 2006
Last Updated:	December 26, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

randomized
non-comparative
efficacy

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel

Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012