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

Condition(s) targeted: Prostatic Neoplasms

Intervention: Docetaxel (Drug); Prednisone (Drug); SU011248 (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer Oncology Clinical Trial Information Service, Phone: 1-877-369-9753, Email: PfizerCancerTrials@emergingmed.com

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).

Official title: A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Metastatic Hormone Refractory Prostate Cancer (HRPC)

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Phase 1 - To evaluate the pharmacokinetics of SU011248 and docetaxel when co-administered with prednisone

Phase 2 - To assess the anti-tumor activity of SU011248 in combination with docetaxel and prednisone (PSA response rate)

Phase 1 - To determine the optimal combination dose and overall safety and tolerability of SU011248 administered in combination with docetaxel and prednisone

Secondary outcome:

Phase 2 - To assess the duration of tumor control (time to PSA progression and duration of PSA response)

Phase 2 - Exploratory analyses of biomarkers

Phase 2 - Patient reported outcomes

Phase 2 - Objective tumor response rate

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- 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

- ECOG performance status 0 or 1

Exclusion Criteria:

- Prior thalidomide, anti-VEGF therapy, VEGF receptor inhibitor, 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, QTC >450 msec

- CNS involvement

Pfizer Oncology Clinical Trial Information Service, Phone: 1-877-369-9753, Email: PfizerCancerTrials@emergingmed.com

Pfizer Investigational Site, Harvey, Illinois 60426, United States; Active, not recruiting

Pfizer Investigational Site, Tinley Park, Illinois 60477, United States; Active, not recruiting

Pfizer Investigational Site, Hobart, Indiana 46342, United States; Active, not recruiting

Pfizer Investigational Site, Munster, Indiana 46321, United States; Active, not recruiting

Pfizer Investigational Site, Durham, North Carolina 27705, United States; Active, not recruiting

Pfizer Investigational Site, Portland, Oregon 97239, United States; Completed

Pfizer Investigational Site, Portland, Oregon 97239-3098, United States; Completed

Pfizer Investigational Site, Myrtle Beach, South Carolina 29572, United States; Active, not recruiting

Pfizer Investigational Site, Clarksville, Tennessee 37043, United States; Completed

Pfizer Investigational Site, Franklin, Tennessee 37067, United States; Completed

Pfizer Investigational Site, Gallarin, Tennessee 37066, United States; Completed

Pfizer Investigational Site, Hermitage, Tennessee 37076, United States; Completed

Pfizer Investigational Site, Lebanon, Tennessee 37087, United States; Completed

Pfizer Investigational Site, Murfreesboro, Tennessee 37130, United States; Completed

Pfizer Investigational Site, Nashville, Tennessee 37203, United States; Completed

Pfizer Investigational Site, Nashville, Tennessee 37205, United States; Completed

Pfizer Investigational Site, Nashville, Tennessee 37207, United States; Completed

Pfizer Investigational Site, Nashville, Tennessee 37211, United States; Completed

Pfizer Investigational Site, Smithville, Tennessee 37166, United States; Completed

Pfizer Investigational Site, Smyrna, Tennessee 37167, United States; Completed

Pfizer Investigational Site, Tullahoma, Tennessee 37388, United States; Completed

Pfizer Investigational Site, Houston, Texas 77030, United States; Recruiting

Pfizer Investigational Site, Dallas, Texas 75246, United States; Active, not recruiting

Pfizer Investigational Site, Madison, Wisconsin 53792, United States; Active, not recruiting

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

Starting date: October 2005
Ending date: June 2010
Last updated: May 8, 2009