Clinical trial NCT00137436: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostatic Neoplasms
Keywords: First-line treatment of metastatic hormone-refractory prostate cancer SUTENT in combination with docetaxel and prednisone
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 93
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 prostate cancer (mHRPC).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Prostate Specific Antigen (PSA) Response
timeFrame: Baseline, Day 1 of each 21-day cycle
Secondary outcomes:
measure: Time to PSA Progression
timeFrame: Baseline to first documentation of PSA progression up to 28 days after date of last dose
measure: Duration of PSA Response (DPR)
timeFrame: Baseline to first documentation of PSA progression up to 28 days after date of last dose
measure: Percentage of Participants With Objective Response Rate (ORR)
timeFrame: Baseline to first documentation of PSA progression up to 28 days after date of last dose
measure: Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC
timeFrame: Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14
measure: Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2
timeFrame: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14
measure: Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3
timeFrame: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14
measure: Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC
timeFrame: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14
measure: Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2
timeFrame: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14
measure: Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3
timeFrame: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14
measure: Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)
timeFrame: 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)
measure: Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)
timeFrame: 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)
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)
timeFrame: 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)
measure: Preliminary Assessment of PSA Modulation by SU011248
timeFrame: Baseline to Day 28
Other outcomes:
Locations:
city: Harvey
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Tinley Park
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Hobart
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Munster
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Myrtle Beach
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Clarksville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Franklin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Gallarin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Hermitage
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Murfreesboro
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Smithville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Smyrna
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Tullahoma
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: