Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment|
|Study Start Date:||May 2002|
|Primary Completion Date:||January 2004 (Final data collection date for primary outcome measure)|
- 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.
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Leuven, Belgium, B-3000|
|Centre Leon Berard|
|Lyon, France, 69008|
|CHU de la Timone|
|Marseille, France, 13385|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Robert Roessle Klinik|
|Berlin, Germany, D-13122|
|Hamburg, Germany, D-20246|
|Medizinische Hochschule Hannover|
|Hannover, Germany, D-30625|
|Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen|
|Munich, Germany, D-81377|
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital|
|Amsterdam, Netherlands, 1066 CX|
|Academisch Ziekenhuis Groningen|
|Groningen, Netherlands, 9700 RB|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Daniel Den Hoed Cancer Center at Erasmus University Medical Center|
|Rotterdam, Netherlands, 3008 AE|
|St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Royal Marsden NHS Trust - London|
|London, England, United Kingdom, SW3 6JJ|
|Northern Centre for Cancer Treatment at Newcastle General Hospital|
|Newcastle Upon Tyne, England, United Kingdom, NE4 6BE|
|Study Chair:||Michael Leahy, MBChB, FRACP, FRCP, FRC Path||Fremantle Hospital|