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)”

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).

Study Type: Interventional

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

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: Docetaxel
  • Docetaxel Phase 1 - escalating doses (60 and 75 mg/m2), IV, administered every 3 weeks. Phase 2 - Phase 1 optimal combination dose (75 mg/m2, IV, every 3 weeks).
• Drug: Prednisone
  • Prednisone Phase1/2 - 5 mg BID, oral.
• Drug: SU011248
  • 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).

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • SU011248 in combination with docetaxel and prednisone

Primary Measures

• Phase 1 - To evaluate the pharmacokinetics of SU011248 and docetaxel when co-administered with prednisone
  • Time Frame: 18 months
    Safety Issue?: Yes
• Phase 2 - To assess the anti-tumor activity of SU011248 in combination with docetaxel and prednisone (PSA response rate)
  • Time Frame: 12 months
    Safety Issue?: No
• Phase 1 - To determine the optimal combination dose and overall safety and tolerability of SU011248 administered in combination with docetaxel and prednisone
  • Time Frame: 18 months
    Safety Issue?: Yes

Secondary Measures

• Phase 2 - To assess the duration of tumor control (time to PSA progression and duration of PSA response)
  • Time Frame: 12 months
    Safety Issue?: No
• Phase 2 - Exploratory analyses of biomarkers
  • Time Frame: 12 months
    Safety Issue?: No
• Phase 2 - Patient reported outcomes
  • Time Frame: 12 months
    Safety Issue?: No
• Phase 2 - Objective tumor response rate
  • Time Frame: 12 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00137436

Study ID Number: A6181043

ClinicalTrials.gov Identifier: NCT00137436

Health Authority: United States: Food and Drug Administration

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