Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
European Organization for Research and Treatment of Cancer |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00041249 |
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.
Condition | Intervention | Phase |
---|---|---|
Gastrointestinal Stromal Tumor Sarcoma |
Drug: brostallicin |
Phase II |
Study Type: | Interventional |
Study Design: | 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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Stratum I
Stratum II
The following sarcoma types are excluded:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Belgium | |
U.Z. Gasthuisberg | |
Leuven, Belgium, B-3000 | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, B-2650 | |
France | |
Centre Leon Berard | |
Lyon, France, 69008 | |
CHU de la Timone | |
Marseille, France, 13385 | |
Institut Gustave Roussy | |
Villejuif, France, F-94805 | |
Germany | |
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen | |
Munich, Germany, D-81377 | |
Medizinische Hochschule Hannover | |
Hannover, Germany, D-30625 | |
Robert Roessle Klinik | |
Berlin, Germany, D-13122 | |
Universitaets-Krankenhaus Eppendorf | |
Hamburg, Germany, D-20246 | |
Netherlands | |
Academisch Ziekenhuis Groningen | |
Groningen, Netherlands, 9700 RB | |
Daniel Den Hoed Cancer Center at Erasmus University Medical Center | |
Rotterdam, Netherlands, 3008 AE | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 RC | |
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | |
Amsterdam, Netherlands, 1066 CX | |
United Kingdom, England | |
Northern Centre for Cancer Treatment at Newcastle General Hospital | |
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
Royal Marsden NHS Trust - London | |
London, England, United Kingdom, SW3 6JJ | |
St. James's University Hospital | |
Leeds, England, United Kingdom, LS9 7TF |
Investigator: | Michael Leahy, MBChB, FRACP, FRCP, FRC Path | Fremantle Hospital |
Study ID Numbers: | CDR0000069456, EORTC-62011 |
Study First Received: | July 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00041249 History of Changes |
Health Authority: | United States: Federal Government |
adult angiosarcoma adult fibrosarcoma adult leiomyosarcoma adult liposarcoma adult neurofibrosarcoma adult synovial sarcoma stage III adult soft tissue sarcoma |
recurrent adult soft tissue sarcoma adult malignant fibrous histiocytoma adult malignant hemangiopericytoma adult rhabdomyosarcoma gastrointestinal stromal tumor stage IV adult soft tissue sarcoma |
Histiocytoma, Malignant Fibrous Fibrosarcoma Digestive System Neoplasms Gastrointestinal Diseases Leiomyosarcoma Histiocytoma, Benign Fibrous Hemangiosarcoma Hemangiopericytoma Recurrence Malignant Fibrous Histiocytoma Sarcoma, Synovial |
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Liposarcoma Digestive System Diseases Histiocytoma Sarcoma Gastrointestinal Neoplasms Synovial Sarcoma Gastrointestinal Stromal Tumors Rhabdomyosarcoma |
Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Histologic Type Digestive System Diseases Neoplasms by Site |
Digestive System Neoplasms Gastrointestinal Diseases Sarcoma Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |