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

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).

Intervention(s) in this Clinical Trial

• Drug: Docetaxel
  • Docetaxel Phase 1 - escalating doses (60 and 75 mg/m2), intravenous therapy (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 twice a day (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

• Percentage of Participants With Prostate Specific Antigen (PSA) Response
  • Time Frame: Baseline, Day 1 of each 21-day cycle
    Safety Issue?: No

Secondary Measures

• Time to PSA Progression
  • Time Frame: Baseline to first documentation of PSA progression up to 28 days after date of last dose
    Safety Issue?: No
• Duration of PSA Response (DPR)
  • Time Frame: Baseline to first documentation of PSA progression up to 28 days after date of last dose
    Safety Issue?: No
• Percentage of Participants With Objective Response Rate (ORR)
  • Time Frame: Baseline to first documentation of PSA progression up to 28 days after date of last dose
    Safety Issue?: No
• Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC
  • Time Frame: Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14
    Safety Issue?: No
• Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2
  • Time Frame: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14
    Safety Issue?: No
• Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3
  • Time Frame: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14
    Safety Issue?: No
• Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC
  • Time Frame: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14
    Safety Issue?: No
• Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2
  • Time Frame: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14
    Safety Issue?: No
• Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3
  • Time Frame: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14
    Safety Issue?: No
• Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)
  • Time Frame: Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)
    Safety Issue?: No
• Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)
  • Time Frame: Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)
    Safety Issue?: No
• Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)
  • Time Frame: Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)
    Safety Issue?: No
• Preliminary Assessment of PSA Modulation by SU011248
  • Time Frame: Baseline to Day 28
    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
• 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

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 Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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