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

NCT00313781 | Completed Phase 2 Results

• 1 other identifier: A4021011
• Study Type: interventional
• Target: 204
• Locations: 6 countries
• Sites: 18

Brief Summary

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

Conditions

Prostatic Neoplasms

Keywords

randomized; non-comparative; efficacy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Prostate Specific Antigen (PSA) Best Response

  Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =\< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as \>= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.

  Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)

Secondary Outcomes (12)

• Progression Free Survival (PFS)

  Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)

• Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)

  Baseline (Day 1 of Cycle 1)

• Human Anti-human Antibody (HAHA) at the Last Follow-up Visit

  The last follow-up visit (150 days post last dose)

• Population PK Parameters of CP-751,871

  Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

• Total Number of Circulation Tumor Cells (CTCs)

  Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)

Study Arms (2)

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; Drug: docetaxel; Drug: prednisone

B

ACTIVE COMPARATOR

Drug: docetaxel; Drug: prednisone

Interventions

CP-751,871 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).

A

docetaxel DRUG

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

A

prednisone DRUG

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

A

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous treatment with chemotherapy

Sponsors & Collaborators

• Pfizer: lead

Study Sites (18)

Pfizer Investigational Site

Los Angeles, California, 90048, United States

Location

Pfizer Investigational Site

New York, New York, 10032, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44106, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44195-0001, United States

Location

Pfizer Investigational Site

Orange, Ohio, 44122, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Pfizer Investigational Site

Montreal, Quebec, H2L 4M1, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3T 1E2, Canada

Location

Pfizer Investigational Site

Berlin, 12200, Germany

Location

Pfizer Investigational Site

München, 81675, Germany

Location

Pfizer Investigational Site

A Coruña, A Coruña, 15006, Spain

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08035, Spain

Location

Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Pfizer Investigational Site

Sankt Gallen, CH-9007, Switzerland

Location

Pfizer Investigational Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Pfizer Investigational Site

Glasgow, G12 0YH, United Kingdom

Location

Pfizer Investigational Site

Glasgow, G52 3NQ, United Kingdom

Location

Pfizer Investigational Site

Guildford, GU2 7WG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24536060 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

figitumumab; Docetaxel; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2006
• First Posted: April 12, 2006
• Study Start: May 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 11, 2013
• Results First Posted: April 11, 2013

Record last verified: 2013-03

Locations

DE (2); CH (1); US (6); CA (2); GB (4); ES (3)