|
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: | NCT00041236 |
Purpose
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 exatecan mesylate in treating patients who have advanced soft tissue sarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: exatecan mesylate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group |
| Study Start Date: | May 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to histological diagnosis (leiomyosarcoma vs other histologies).
Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks until disease progression. After disease progression, patients are followed every 12 weeks for survival.
PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 15 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed soft tissue sarcoma
The following tumor types are excluded:
Prior chemotherapy for metastatic disease required
Must have 1 measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Belgium | |
| Cliniques Universitaires Saint-Luc | |
| Brussels, Belgium, 1200 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Denmark | |
| Aarhus University Hospital - Aarhus Sygehus - Norrebrogade | |
| Aarhus, Denmark, DK-8000 | |
| Germany | |
| Eberhard Karls Universitaet | |
| Tuebingen, Germany, D-72076 | |
| Medizinische Hochschule Hannover | |
| Hannover, Germany, D-30625 | |
| Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch | |
| Berlin, Germany, D-13122 | |
| Universitaetsklinikum Essen | |
| Essen, Germany, D-45122 | |
| Universitaets-Krankenhaus Eppendorf | |
| Hamburg, Germany, D-20246 | |
| Universitatsklinikum Carl Gustav Carl Carus | |
| Dresden, Germany, D-01307 | |
| Slovakia | |
| National Cancer Institute - Bratislava | |
| Bratislava, Slovakia, 833 10 | |
| Investigator: | Peter Reichardt, MD | Robert Roessle Comprehensive Cancer Center - Charite Campus Buch |
More Information
| Study ID Numbers: | CDR0000069455, EORTC-62006 |
| Study First Received: | July 8, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00041236 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult angiosarcoma adult fibrosarcoma adult leiomyosarcoma adult liposarcoma adult neurofibrosarcoma adult synovial sarcoma stage IV adult soft tissue sarcoma |
recurrent adult soft tissue sarcoma adult malignant fibrous histiocytoma adult malignant hemangiopericytoma adult rhabdomyosarcoma stage IV uterine sarcoma recurrent uterine sarcoma uterine leiomyosarcoma |
|
Histiocytoma, Malignant Fibrous Fibrosarcoma Leiomyosarcoma Histiocytoma, Benign Fibrous DX 8951 Hemangiosarcoma Hemangiopericytoma Camptothecin Recurrence Malignant Fibrous Histiocytoma Sarcoma, Synovial |
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Liposarcoma Histiocytoma Uterine Sarcoma Sarcoma Synovial Sarcoma Antineoplastic Agents, Phytogenic Rhabdomyosarcoma |
|
Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Sarcoma Enzyme Inhibitors DX 8951 Antineoplastic Agents, Phytogenic Pharmacologic Actions Camptothecin |