NCT00879619

Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients

A Pilot Phase I/II Study to Evaluate the Effects of Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients With Biochemical Relapse

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: John P. Fruehauf · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel and prednisone together with sunitinib malate may kill more tumor cells. PURPOSE: This pilot phase I/II trial studies the side effects and best way to give docetaxel and prednisone together with sunitinib malate and to see how well it works in treating patients with prostate cancer that progressed after hormone therapy.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the response by prostate specific antigen (PSA) of docetaxel/prednisone plus sunitinib (sunitinib malate) in chemotherapy-naive, hormone refractory prostate cancer subjects with biochemical relapse. SECONDARY OBJECTIVES: I. To determine the objective response rate (ORR) and duration of response (DR) in subjects with measurable disease. II. To determine overall survival (OS) and time to progression (TTP). III. To evaluate the safety and tolerability of sunitinib in combination with docetaxel and prednisone. OUTLINE: Patients receive docetaxel intravenously (IV) over 60 minutes on day 1, prednisone orally (PO) twice daily (BID) on days 1-21, and sunitinib malate PO once daily (QD) on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for 3 years.

Conditions

• Prostate Cancer
• Adenocarcinoma of the Prostate
• Recurrent Prostate Cancer
• Stage I Prostate Cancer
• Stage III Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	sunitinib malate	Given PO
DRUG	docetaxel	Given IV
DRUG	prednisone	Given PO

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-10-01
• Completion: 2011-11-01
• First posted: 2009-04-10
• Last updated: 2017-02-01
• Results posted: 2013-06-06

Locations

1 site across 1 country: United States