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

Sponsored by:	Pfizer
Information provided by:	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

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Docetaxel

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

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 ]

Estimated Enrollment:	120
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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.
B: Active Comparator	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

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

United States, California
Pfizer Investigational Site	Recruiting
Los Angeles, California, United States, 90048
United States, New York
Pfizer Investigational Site	Recruiting
New York, New York, United States, 10032
United States, Ohio
Pfizer Investigational Site	Completed
Cleveland, Ohio, United States, 44195-0001
Pfizer Investigational Site	Recruiting
Cleveland, Ohio, United States, 44106
Pfizer Investigational Site	Recruiting
Orange Village, Ohio, United States, 44122
Pfizer Investigational Site	Recruiting
South Euclid, Ohio, United States, 44121
United States, Pennsylvania
Pfizer Investigational Site	Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Canada, Quebec
Pfizer Investigational Site	Recruiting
Montreal, Quebec, Canada, H3T 1E2
Pfizer Investigational Site	Recruiting
Montreal, Quebec, Canada, H2L 4M1
Germany
Pfizer Investigational Site	Recruiting
Berlin, Germany, 12200
Pfizer Investigational Site	Recruiting
Muenchen, Germany, 81675
Spain
Pfizer Investigational Site	Recruiting
A CORUÑA, Spain, 15006
Pfizer Investigational Site	Recruiting
BARCELONA, Spain, 08035
Spain, BARCELONA
Pfizer Investigational Site	Recruiting
HOSPITALET DE LLOBREGAT, BARCELONA, Spain, 08907
Switzerland
Pfizer Investigational Site	Recruiting
St. Gallen, Switzerland, CH-9007
United Kingdom
Pfizer Investigational Site	Recruiting
Guildford, United Kingdom, GU2 7WG
Pfizer Investigational Site	Recruiting
Glasgow, United Kingdom, G12 0YH
United Kingdom, Surrey
Pfizer Investigational Site	Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4021011
Study First Received:	April 10, 2006
Last Updated:	December 20, 2008
ClinicalTrials.gov Identifier:	NCT00313781
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

randomized, non-comparative, efficacy

Study placed in the following topic categories:

Docetaxel
Prednisone
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009