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

Completed · Phase 1/Phase 2

Conditions studied: Prostatic Neoplasms

In brief

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).

Key facts

Study ID

NCT00137436

Run by

Pfizer

People needed

93

Starts

2005-10-01

Expected to finish

2010-03-01

Last updated by the study team

2011-08-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• Pfizer Investigational Site — Harvey, Illinois, United States
• Pfizer Investigational Site — Tinley Park, Illinois, United States
• Pfizer Investigational Site — Hobart, Indiana, United States
• Pfizer Investigational Site — Munster, Indiana, United States
• Pfizer Investigational Site — Durham, North Carolina, United States
• Pfizer Investigational Site — Portland, Oregon, United States
• Pfizer Investigational Site — Portland, Oregon, United States
• Pfizer Investigational Site — Myrtle Beach, South Carolina, United States
• Pfizer Investigational Site — Clarksville, Tennessee, United States
• Pfizer Investigational Site — Franklin, Tennessee, United States
• Pfizer Investigational Site — Gallarin, Tennessee, United States
• Pfizer Investigational Site — Hermitage, Tennessee, United States
• Pfizer Investigational Site — Lebanon, Tennessee, United States
• Pfizer Investigational Site — Murfreesboro, Tennessee, United States
• Pfizer Investigational Site — Nashville, Tennessee, United States
• Pfizer Investigational Site — Nashville, Tennessee, United States
• Pfizer Investigational Site — Nashville, Tennessee, United States
• Pfizer Investigational Site — Nashville, Tennessee, United States
• Pfizer Investigational Site — Smithville, Tennessee, United States
• Pfizer Investigational Site — Smyrna, Tennessee, United States
• Pfizer Investigational Site — Tullahoma, Tennessee, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — Houston, Texas, United States
• Pfizer Investigational Site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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