Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer

NCT00137436 | Completed Phase 1 Results

• 1 other identifier: A6181043
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 24

Brief Summary

This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC).

Conditions

Prostatic Neoplasms

Keywords

First-line treatment of metastatic hormone-refractory prostate cancer SUTENT in combination with docetaxel and prednisone

Outcome Measures

Primary Outcomes (1)

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

  PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.

  Baseline, Day 1 of each 21-day cycle

Secondary Outcomes (13)

• Time to PSA Progression

  Baseline to first documentation of PSA progression up to 28 days after date of last dose

• Duration of PSA Response (DPR)

  Baseline to first documentation of PSA progression up to 28 days after date of last dose

• Percentage of Participants With Objective Response Rate (ORR)

  Baseline to first documentation of PSA progression up to 28 days after date of last dose

• Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC

  Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14

• Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2

  Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14

Study Arms (1)

A

EXPERIMENTAL

SU011248 in combination with docetaxel and prednisone

Drug: Docetaxel; Drug: Prednisone; Drug: SU011248

Interventions

Docetaxel DRUG

Docetaxel Phase 1 - escalating doses (60 and 75 mg/m2), intravenous therapy (IV), administered every 3 weeks. Phase 2 - Phase 1 optimal combination dose (75 mg/m2, IV, every 3 weeks).

Also known as: Taxotere; Sunitinib malate; SUTENT

A

Prednisone DRUG

Prednisone Phase1/2 - 5 mg twice a day (BID), oral.

A

SU011248 DRUG

SU011248 Phase 1 - escalating doses (12.5, 37.5, and 50 mg), oral, administered on a 2-weeks on, 1-week off daily regimen (Schedule 2/1). Phase 2 - Phase 1 optimal combination dose (37.5 mg/day, oral, Schedule 2/1).

A

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Patients must have progressive hormone-refractory prostate cancer (HRPC): patients must have undergone primary hormone treatment (e.g. orchiectomy or gonadotropin releasing hormone analog with or without antiandrogens). For patients who received antiandrogen therapy, disease progression must have been determined after antiandrogen discontinuation
• Progressive disease based on either non-measurable disease and an elevated PSA OR measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

You may not qualify if:

• Prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitor, platelet-derived growth factor (PDGF) receptor inhibitor or anti-angiogenic treatment of any kind including investigational therapy
• Prior chemotherapy
• Uncontrolled pain at baseline, impending complication from bone metastasis (fracture and/or compression) and/or presence of urinary obstruction (urinary retention, hydronephrosis)
• History of cardiac dysfunction, QT interval corrected for heart rate (QTc) \>450 msec
• Central Nervous System (CNS) involvement

Sponsors & Collaborators

• Pfizer: lead

Study Sites (24)

Pfizer Investigational Site

Harvey, Illinois, 60426, United States

Location

Pfizer Investigational Site

Tinley Park, Illinois, 60477, United States

Location

Pfizer Investigational Site

Hobart, Indiana, 46342, United States

Location

Pfizer Investigational Site

Munster, Indiana, 46321, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27710, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97239-3098, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97239, United States

Location

Pfizer Investigational Site

Myrtle Beach, South Carolina, 29572, United States

Location

Pfizer Investigational Site

Clarksville, Tennessee, 37043, United States

Location

Pfizer Investigational Site

Franklin, Tennessee, 37067, United States

Location

Pfizer Investigational Site

Gallarin, Tennessee, 37066, United States

Location

Pfizer Investigational Site

Hermitage, Tennessee, 37076, United States

Location

Pfizer Investigational Site

Lebanon, Tennessee, 37087, United States

Location

Pfizer Investigational Site

Murfreesboro, Tennessee, 37130, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37203, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37205, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37207, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37211, United States

Location

Pfizer Investigational Site

Smithville, Tennessee, 37166, United States

Location

Pfizer Investigational Site

Smyrna, Tennessee, 37167, United States

Location

Pfizer Investigational Site

Tullahoma, Tennessee, 37388, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75246, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53792, United States

Location

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Sunitinib; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Per FDAAA, only the Phase 2 study results are posted.

Results Point of Contact

• Title: Pfizer Clinical Trials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 29, 2005
• Study Start: October 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: March 1, 2010
• Last Updated: August 29, 2011
• Results First Posted: February 23, 2010

Record last verified: 2011-08

Locations

US (24)