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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2010-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

SU011248 in combination with docetaxel and prednisone

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

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).

Prednisone

Intervention Type DRUG

Prednisone Phase1/2 - 5 mg twice a day (BID), oral.

SU011248

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Prednisone

Prednisone Phase1/2 - 5 mg twice a day (BID), oral.

Intervention Type 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).

Intervention Type DRUG

Other Intervention Names

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Taxotere; Sunitinib malate; SUTENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No