Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00137436

Purpose

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).

Condition	Intervention	Phase
Prostatic Neoplasms	Drug: Docetaxel Drug: Prednisone Drug: SU011248	Phase I Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Docetaxel Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Phase 1 - To evaluate the pharmacokinetics of SU011248 and docetaxel when co-administered with prednisone [ Time Frame: 18 months ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Phase 2 - To assess the duration of tumor control (time to PSA progression and duration of PSA response) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Phase 2 - Exploratory analyses of biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Phase 2 - Patient reported outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Phase 2 - Objective tumor response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	92
Study Start Date:	October 2005
Estimated Study Completion Date:	June 2010
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental SU011248 in combination with docetaxel and prednisone	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

Assigned Interventions

A: Experimental

SU011248 in combination with docetaxel and prednisone

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137436

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

United States, Illinois
Pfizer Investigational Site	Active, not recruiting
Harvey, Illinois, United States, 60426
Pfizer Investigational Site	Active, not recruiting
Tinley Park, Illinois, United States, 60477
United States, Indiana
Pfizer Investigational Site	Active, not recruiting
Hobart, Indiana, United States, 46342
Pfizer Investigational Site	Active, not recruiting
Munster, Indiana, United States, 46321
United States, North Carolina
Pfizer Investigational Site	Active, not recruiting
Durham, North Carolina, United States, 27705
United States, Oregon
Pfizer Investigational Site	Completed
Portland, Oregon, United States, 97239
Pfizer Investigational Site	Completed
Portland, Oregon, United States, 97239-3098
United States, South Carolina
Pfizer Investigational Site	Active, not recruiting
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Pfizer Investigational Site	Completed
Clarksville, Tennessee, United States, 37043
Pfizer Investigational Site	Completed
Franklin, Tennessee, United States, 37067
Pfizer Investigational Site	Completed
Gallarin, Tennessee, United States, 37066
Pfizer Investigational Site	Completed
Hermitage, Tennessee, United States, 37076
Pfizer Investigational Site	Completed
Lebanon, Tennessee, United States, 37087
Pfizer Investigational Site	Completed
Murfreesboro, Tennessee, United States, 37130
Pfizer Investigational Site	Completed
Nashville, Tennessee, United States, 37203
Pfizer Investigational Site	Completed
Nashville, Tennessee, United States, 37205
Pfizer Investigational Site	Completed
Nashville, Tennessee, United States, 37207
Pfizer Investigational Site	Completed
Nashville, Tennessee, United States, 37211
Pfizer Investigational Site	Completed
Smithville, Tennessee, United States, 37166
Pfizer Investigational Site	Completed
Smyrna, Tennessee, United States, 37167
Pfizer Investigational Site	Completed
Tullahoma, Tennessee, United States, 37388
United States, Texas
Pfizer Investigational Site	Recruiting
Houston, Texas, United States, 77030
Pfizer Investigational Site	Active, not recruiting
Dallas, Texas, United States, 75246
United States, Wisconsin
Pfizer Investigational Site	Active, not recruiting
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181043
Study First Received:	August 26, 2005
Last Updated:	May 8, 2009
ClinicalTrials.gov Identifier:	NCT00137436 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

First-line treatment of metastatic hormone-refractory prostate cancer SUTENT in combination with docetaxel and prednisone

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Angiogenesis Inhibitors

Glucocorticoids
Hormones
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Sunitinib
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010