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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

CP-751,871

docetaxel

prednisone

docetaxel

prednisone

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring randomized, non-comparative, efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of metastatic, progressive hormone refractory prostate cancer Adequate bone marrow, liver and kidney function Exclusion Criteria: Previous treatment with chemotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

Levels of HAHA in serum were detected at baseline.

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

Levels of HAHA in serum were detected at the last follow-up visit.

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

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.

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.

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.

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.

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.

Maximum Observed Plasma Concentration (Cmax) for CP-751,871

Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871

Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871

Full Information

NCT ID

NCT00313781

First Posted

April 10, 2006

Last Updated

March 5, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00313781

Brief Title

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

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms

Keywords

randomized, non-comparative, efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

204 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Experimental

Arm Description

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.

Arm Title

B

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

CP-751,871

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

docetaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

prednisone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

docetaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

prednisone

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

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)

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

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.

Time Frame

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

Title

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

Description

Levels of HAHA in serum were detected at baseline.

Time Frame

Baseline (Day 1 of Cycle 1)

Title

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

Description

Levels of HAHA in serum were detected at the last follow-up visit.

Time Frame

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

Title

Population PK Parameters of CP-751,871

Description

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

Time Frame

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

Title

Total Number of Circulation Tumor Cells (CTCs)

Description

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.

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)

Title

Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs

Description

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.

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)

Title

Quality of Life Measured by the Functional Assessment of Cancer Treatment-Prostate (FACT-P)

Description

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.

Time Frame

Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)

Title

Pain Measured by the Modified Brief Pain Inventory-Short Form (mBPI-sf Modified Pfizer)

Description

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.

Time Frame

Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)

Title

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871

Description

Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration.

Time Frame

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

Title

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)

Title

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)

Title

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)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195-0001

Country

United States

Facility Name

Pfizer Investigational Site

City

Orange Village

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111-2497

Country

United States

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Pfizer Investigational Site

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Pfizer Investigational Site

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Pfizer Investigational Site

City

St. Gallen

ZIP/Postal Code

CH-9007

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Glasgow

ZIP/Postal Code

G12 0YH

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Glasgow

ZIP/Postal Code

G52 3NQ

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Guildford

ZIP/Postal Code

GU2 7WG

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

24536060

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4021011&StudyName=Study%20of%20CP-751%2C871%20in%20Combination%20With%20Docetaxel%20and%20Prednisone%20in%20Patients%20with%20Hormone%20Insensitive%20Prostate%20Cancer%20%28HRPC%29

Description

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Prostatic Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial