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

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ClinicalTrials.gov Identifier: NCT00313781
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : April 11, 2013
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: CP-751,871 Drug: docetaxel Drug: prednisone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2006
Actual Primary Completion Date : April 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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) ]
  11. 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) ]
  12. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313781


Locations
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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
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00313781     History of Changes
Other Study ID Numbers: A4021011
First Posted: April 12, 2006    Key Record Dates
Results First Posted: April 11, 2013
Last Update Posted: April 11, 2013
Last Verified: March 2013

Keywords provided by Pfizer:
randomized
non-comparative
efficacy

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Prednisone
Hormones
Antibodies, Monoclonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Antineoplastic Agents, Hormonal
Immunologic Factors