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

March 5, 2013 updated by: Pfizer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous treatment with chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Prostate Specific Antigen (PSA) Best Response
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)
PFS was defined as the time from randomization to first event of disease progression. Disease progression events were defined as the following: PSA progression,objective disease progression as per RECIST, death, and discontinuation of treatment due to symptomatic deterioration. PSA progression was defined as the time-point of PSA progression on 2 successive evaluations taken 1 week apart after dosing in cycle 3.
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)
Time Frame: Baseline (Day 1 of Cycle 1)
Levels of HAHA in serum were detected at baseline.
Baseline (Day 1 of Cycle 1)
Human Anti-human Antibody (HAHA) at the Last Follow-up Visit
Time Frame: The last follow-up visit (150 days post last dose)
Levels of HAHA in serum were detected at the last follow-up visit.
The last follow-up visit (150 days post last dose)
Population PK Parameters of CP-751,871
Time Frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-751,871 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-751,871 concentrations
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)
Time Frame: 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)
Blood samples were collected and processed to enumerate the number of total CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive epithelial cell adhesion molecule (EpCAM) and cytokeratin staining.
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)
Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs
Time Frame: 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)
Blood samples were collected to enumerate the number of total IGF-1R positive CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive EpCAM and cytokeratin staining. A separate CellSave tube of cells was also collected and processed with cell surface staining of IGF-1R to enumerate surfaces of IGF-1R-positive 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)
Quality of Life Measured by the Functional Assessment of Cancer Treatment-Prostate (FACT-P)
Time Frame: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)
The FACT-P was a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The total FACT-P score ranged from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represented the best outcome.
Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)
Pain Measured by the Modified Brief Pain Inventory-Short Form (mBPI-sf Modified Pfizer)
Time Frame: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)
The mBPI-sf was a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the worst pain item of the mBPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an "X" in one of the 10 boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuraxial block.
Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871
Time Frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration.
Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Maximum Observed Plasma Concentration (Cmax) for CP-751,871
Time Frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871
Time Frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871
Time Frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 10, 2006

First Submitted That Met QC Criteria

April 10, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4021011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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