Clinical trial NCT00313781: Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Keywords: randomized
non-comparative
efficacy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 204
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Previous treatment with chemotherapy

Primary outcomes:
measure: Percentage of Participants With Prostate Specific Antigen (PSA) Best Response
timeFrame: 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:
measure: Progression Free Survival (PFS)
timeFrame: Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)
measure: Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)
timeFrame: Baseline (Day 1 of Cycle 1)
measure: Human Anti-human Antibody (HAHA) at the Last Follow-up Visit
timeFrame: The last follow-up visit (150 days post last dose)
measure: Population PK Parameters of CP-751,871
timeFrame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
measure: Total Number of Circulation Tumor Cells (CTCs)
timeFrame: 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)
measure: Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs
timeFrame: 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)
measure: Quality of Life Measured by the Functional Assessment of Cancer Treatment-Prostate (FACT-P)
timeFrame: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)
measure: Pain Measured by the Modified Brief Pain Inventory-Short Form (mBPI-sf Modified Pfizer)
timeFrame: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871
timeFrame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
measure: Maximum Observed Plasma Concentration (Cmax) for CP-751,871
timeFrame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
measure: Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871
timeFrame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871
timeFrame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Orange Village
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: A Coruña
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: St. Gallen
country: Switzerland
facility: Pfizer Investigational Site
city: Sutton
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Guildford
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.