Trials / Completed
CompletedNCT00041249
Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- 15 Years
- 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 brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.
Detailed description
OBJECTIVES: * Determine the antitumor activity of brostallicin, in terms of objective response, in patients with locally advanced or metastatic soft tissue sarcoma who have failed one prior chemotherapy treatment. * Determine the time to progression and duration of response in patients treated with this drug. * Determine the safety and toxic effects of this drug in these patients. * Correlate clinical outcome with whole blood glutathione level in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to tumor (tumors other than gastrointestinal stromal tumor (GIST) vs GIST). Patients receive brostallicin IV over 10 minutes on day 1. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 4 months for 1 year. PROJECTED ACCRUAL: A total of 58-72 patients (40 for stratum I and 18-32 for stratum II) will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | brostallicin |
Timeline
- Start date
- 2002-05-01
- Primary completion
- 2004-01-01
- First posted
- 2003-01-27
- Last updated
- 2012-07-18
Locations
16 sites across 5 countries: Belgium, France, Germany, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT00041249. Inclusion in this directory is not an endorsement.