NCT00003626

Dolastatin 10 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Hormone Therapy

Phase II Evaluation of Dolastatin-10 in Patients With Hormone Refractory Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.

Detailed description

OBJECTIVES: I. Determine the objective response rate in patients with hormone refractory prostate cancer treated with dolastatin 10. II. Determine the toxicity of this regimen in this patient population. OUTLINE: Patients receive dolastatin 10 IV bolus every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	dolastatin 10

Timeline

• Start date: 1998-10-01
• Primary completion: 1999-12-01
• Completion: 2000-05-01
• First posted: 2004-08-17
• Last updated: 2013-04-05

Locations

3 sites across 1 country: United States