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

NCT ID: NCT00313781

Last Updated: 2013-04-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2011-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CP-751,871

Intervention Type DRUG

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).

docetaxel

Intervention Type DRUG

Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.

prednisone

Intervention Type DRUG

Prednisone is administered at a dose of 5 mg twice daily.

B

Group Type ACTIVE_COMPARATOR

docetaxel

Intervention Type DRUG

Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.

prednisone

Intervention Type DRUG

Prednisone is administered at a dose of 5 mg twice daily.

Interventions

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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).

Intervention Type DRUG

docetaxel

Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.

Intervention Type DRUG

prednisone

Prednisone is administered at a dose of 5 mg twice daily.

Intervention Type DRUG

docetaxel

Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.

Intervention Type DRUG

prednisone

Prednisone is administered at a dose of 5 mg twice daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previous treatment with chemotherapy
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Pfizer Investigational Site

Orange, Ohio, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Montreal, Quebec, Canada

Site Status

Pfizer Investigational Site

Montreal, Quebec, Canada

Site Status

Pfizer Investigational Site

Berlin, , Germany

Site Status

Pfizer Investigational Site

München, , Germany

Site Status

Pfizer Investigational Site

A Coruña, A Coruña, Spain

Site Status

Pfizer Investigational Site

Barcelona, Barcelona, Spain

Site Status

Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Pfizer Investigational Site

Sankt Gallen, , Switzerland

Site Status

Pfizer Investigational Site

Sutton, Surrey, United Kingdom

Site Status

Pfizer Investigational Site

Glasgow, , United Kingdom

Site Status

Pfizer Investigational Site

Glasgow, , United Kingdom

Site Status

Pfizer Investigational Site

Guildford, , United Kingdom

Site Status

Countries

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United States Canada Germany Spain Switzerland United Kingdom

References

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de Bono JS, Piulats JM, Pandha HS, Petrylak DP, Saad F, Aparicio LM, Sandhu SK, Fong P, Gillessen S, Hudes GR, Wang T, Scranton J, Pollak MN. Phase II randomized study of figitumumab plus docetaxel and docetaxel alone with crossover for metastatic castration-resistant prostate cancer. Clin Cancer Res. 2014 Apr 1;20(7):1925-34. doi: 10.1158/1078-0432.CCR-13-1869. Epub 2014 Feb 17.

Reference Type DERIVED
PMID: 24536060 (View on PubMed)

Related Links

Other Identifiers

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A4021011

Identifier Type: -

Identifier Source: org_study_id

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