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

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NCT00137436

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Study Location
Pfizer Investigational Site
Harvey, Illinois, 60426, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostatic Neoplasms
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE
  • 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).
    Other Name: Taxotere; Sunitinib malate; SUTENT
  • 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).
Study Arms  ICMJE Experimental: A
SU011248 in combination with docetaxel and prednisone
Interventions:
  • Drug: Docetaxel
  • Drug: Prednisone
  • Drug: SU011248
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2010)		93
Original Enrollment  ICMJE
 (submitted: August 26, 2005)		72
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137436
Other Study ID Numbers  ICMJE A6181043
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP