Spots Global Cancer Trial Database for Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

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Trial Identification

Brief Title: Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

Official Title: A Phase II Study of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, to Patients With Advanced or Metastatic Soft Tissue Sarcomas (STS) With Prior Exposure to Anthracycline-Based Chemotherapy

Study ID: NCT00064220

Conditions

Sarcoma

Interventions

soblidotin

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have advanced or metastatic soft tissue sarcoma.

Detailed Description: OBJECTIVES: * Determine the objective tumor response rate in patients with advanced or metastatic soft tissue sarcoma with prior exposure to anthracycline-based chemotherapy when treated with soblidotin. * Determine the duration of response in patients treated with this drug. * Determine the time to tumor progression in patients treated with this drug. * Determine the median survival time and 12-month survival rate of patients treated with this drug. * Determine the quantitative and qualitative toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive soblidotin IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 12 months.