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

Back to Search
Print
Bookmark Trial

NCT00137436

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Harvey, Illinois, 60426, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Prostatic NeoplasmsA Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
NCT01288911
  1. Homewood, Alabama
  2. Anchorage, Alaska
  3. Tucson, Arizona
  4. Highland, California
  5. San Diego, California
  6. Denver, Colorado
  7. Middlebury, Connecticut
  8. Melrose Park, Illinois
  9. Springfield, Illinois
  10. Jeffersonville, Indiana
  11. West Des Moines, Iowa
  12. Kansas City, Kansas
  13. Baltimore, Maryland
  14. Bethesda, Maryland
  15. Ann Arbor, Michigan
  16. Grand Rapids, Michigan
  17. Minneapolis, Minnesota
  18. Billings, Montana
  19. Lawrenceville, New Jersey
  20. Poughkeepsie, New York
  21. Rochester, New York
  22. Staten Island, New York
  23. Chapel Hill, North Carolina
  24. Greensboro, North Carolina
  25. Cincinnati, Ohio
  26. Columbus, Ohio
  27. Bala-Cynwyd, Pennsylvania
  28. Lancaster, Pennsylvania
  29. Myrtle Beach, South Carolina
  30. Nashville, Tennessee
  31. Houston, Texas
  32. San Antonio, Texas
  33. Virginia Beach, Virginia
  34. Burien, Washington
  35. Wenatchee, Washington
  36. Milwaukee, Wisconsin
  37. Brussels,
  38. Gent,
  39. Kortrijk,
  40. Leuven,
  41. Liege,
  42. Turnhout,
  43. Calgary, Alberta
  44. Abbotsford, British Columbia
  45. Kingston, Ontario
  46. Toronto, Ontario
  47. Toronto, Ontario
  48. Granby, Quebec
  49. Montreal, Quebec
  50. Aalborg,
  51. Aarhus,
  52. Copenhagen,
  53. Herlev,
  54. Creteil,
  55. Lille,
  56. Lyon Cedex 3,
  57. Paris Cedex 10,
  58. Poitiers Cedex,
  59. Rennes Cedex,
  60. Rouen,
  61. Suresnes Cedex,
  62. Nuertingen, Baden-Wuerttemberg
  63. Aachen,
  64. Bergisch Gladbach,
  65. Bonn,
  66. Bonn,
  67. Bonn,
  68. Hamburg,
  69. Hannover,
  70. Reutlingen,
  71. Waldshut-Tiengen,
  72. Wuppertal,
  73. Bucharest, RO
  74. Bucharest, RO
  75. Bucharest,
  76. Bristol, UK
  77. London, UK
  78. London, UK
  79. Cardiff, Wales
  80. Belfast,
  81. Cambridge,
  82. Glasgow,
  83. Leicher,
  84. London,
  85. Manchester,
  86. Merseyside,
  87. Northwood, Middlesex,
  88. Preston,
Male
18 Years+
years
MULTIPLE SITES
Prostatic NeoplasmsStudy Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer
NCT00137436
  1. Harvey, Illinois
  2. Tinley Park, Illinois
  3. Hobart, Indiana
  4. Munster, Indiana
  5. Durham, North Carolina
  6. Portland, Oregon
  7. Portland, Oregon
  8. Myrtle Beach, South Carolina
  9. Clarksville, Tennessee
  10. Franklin, Tennessee
  11. Gallarin, Tennessee
  12. Hermitage, Tennessee
  13. Lebanon, Tennessee
  14. Murfreesboro, Tennessee
  15. Nashville, Tennessee
  16. Nashville, Tennessee
  17. Nashville, Tennessee
  18. Nashville, Tennessee
  19. Smithville, Tennessee
  20. Smyrna, Tennessee
  21. Tullahoma, Tennessee
  22. Dallas, Texas
  23. Houston, Texas
  24. Madison, Wisconsin
Male
18 Years+
years
MULTIPLE SITES
Prostatic NeoplasmsAn Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients
NCT00235794
  1. Houston, Texas
Male
18 Years+
years
MULTIPLE SITES
Prostatic NeoplasmsA Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
NCT02616185
  1. Morristown, New Jersey
  2. Whippany, New Jersey
  3. Tucson, Arizona
  4. Tucson, Arizona
  5. Golden, Colorado
  6. New Haven, Connecticut
  7. Bethesda, Maryland
  8. Bethesda, Maryland
  9. Creve Coeur, Missouri
  10. Saint Louis, Missouri
  11. Saint Louis, Missouri
  12. Saint Louis, Missouri
  13. Omaha, Nebraska
  14. Las Vegas, Nevada
  15. Morristown, New Jersey
  16. Morristown, New Jersey
  17. Rockaway, New Jersey
  18. Lake Success, New York
  19. New York, New York
  20. New York, New York
  21. New York, New York
  22. New York, New York
  23. Durham, North Carolina
  24. Durham, North Carolina
  25. Pittsburgh, Pennsylvania
  26. Seattle, Washington
  27. Seattle, Washington
Male
18 Years+
years
MULTIPLE SITES
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