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

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313781
• Other study ID #: A4021011
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2006
• Last updated: March 5, 2013
• Start date: May 2006
• Est. completion date: December 2011

Study information

• Verified date: March 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of metastatic, progressive hormone refractory prostate cancer

• Adequate bone marrow, liver and kidney function

Exclusion Criteria:

• Previous treatment with chemotherapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

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).
• docetaxel
Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
• prednisone
Prednisone is administered at a dose of 5 mg twice daily.
• docetaxel
Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
• prednisone
Prednisone is administered at a dose of 5 mg twice daily.

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Muenchen
Spain	Pfizer Investigational Site	A Coruña
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Hospitalet de Llobregat	Barcelona
Switzerland	Pfizer Investigational Site	St. Gallen
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	Guildford
United Kingdom	Pfizer Investigational Site	Sutton	Surrey
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Orange Village	Ohio
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Progression Free Survival (PFS)	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)	No
Secondary	Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)	Levels of HAHA in serum were detected at baseline.	Baseline (Day 1 of Cycle 1)	No
Secondary	Human Anti-human Antibody (HAHA) at the Last Follow-up Visit	Levels of HAHA in serum were detected at the last follow-up visit.	The last follow-up visit (150 days post last dose)	No
Secondary	Population PK Parameters of CP-751,871	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)	No
Secondary	Total Number of Circulation Tumor Cells (CTCs)	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)	No
Secondary	Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs	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)	No
Secondary	Quality of Life Measured by the Functional Assessment of Cancer Treatment-Prostate (FACT-P)	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)	No
Secondary	Pain Measured by the Modified Brief Pain Inventory-Short Form (mBPI-sf Modified Pfizer)	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)	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871	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)	No
Secondary	Maximum Observed Plasma Concentration (Cmax) for CP-751,871		Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)	No
Secondary	Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871		Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)	No
Secondary	Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871		Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)	No

External Links

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