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

Pfizer

Status and phase

Completed

Phase 2

Phase 1

Conditions

Prostatic Neoplasms

Treatments

Drug: Prednisone

Drug: SU011248

Drug: Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00137436

A6181043

Details and patient eligibility

About

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).

Enrollment

93 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria

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