Status:
COMPLETED
Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer
Lead Sponsor:
Pfizer
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00137436
Start Date
October 1 2005
End Date
March 1 2010
Last Update
August 29 2011
Active Locations (24)
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1
Pfizer Investigational Site
Harvey, Illinois, United States, 60426
2
Pfizer Investigational Site
Tinley Park, Illinois, United States, 60477
3
Pfizer Investigational Site
Hobart, Indiana, United States, 46342
4
Pfizer Investigational Site
Munster, Indiana, United States, 46321