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Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma Clinical research trials and Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma. Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma  Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
For Condition: uterine sarcoma,uterine leiomyosarcoma,adult soft tissue sarcoma
Status: Recruiting
Sponsor(s): EORTC Soft Tissue and Bone Sarcoma Cooperative Group ,
Synopsis: 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.
Details: OBJECTIVES: - Determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma. - Determine the safety of this drug in these patients. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed soft tissue sarcoma - Malignant fibrous histiocytoma - Liposarcoma - Rhabdomyosarcoma - Synovial sarcoma - Malignant paraganglioma - Fibrosarcoma - Leiomyosarcoma - Angiosarcoma including hemangiopericytoma - Malignant peripheral nerve sheath tumor - Unclassified sarcoma - Miscellaneous sarcoma including mixed mesodermal tumors of the uterus - The following tumor types are excluded: - Gastrointestinal stromal tumor - Chondrosarcoma - Malignant mesothelioma - Neuroblastoma - Osteosarcoma - Ewing's sarcoma - Embryonal rhabdomyosarcoma - Prior chemotherapy for metastatic disease required - One line of combination chemotherapy containing anthracycline OR - No more than 2 single-agent regimens including anthracycline - Adjuvant chemotherapy not considered first line unless tumor progresses within 6 months after treatment - Must have 1 measurable lesion - Clinical evidence of progression within 6 weeks prior to study - Osseous lesions and pleural effusions not considered measurable - No known or symptomatic CNS metastases PATIENT CHARACTERISTICS: Age: - 15 to 75 Performance status: - WHO 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 4,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.8 mg/dL - Albumin at least 2.5 g/dL Renal: - Creatinine no greater than 1.4 mg/dL OR - Creatinine clearance greater than 65 mL/min Cardiovascular: - No history of severe cardiovascular disease Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for up to 6 months after study participation - No other severe medical illness, including psychosis - No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - More than 4 weeks since prior chemotherapy - No other concurrent cytotoxic therapy Endocrine therapy: - Not specified Radiotherapy: - No radiotherapy to the sole measurable lesion - No concurrent radiotherapy Surgery: - Not specified Other: - No other investigational drugs for 28 days prior to, during, and for 28 days after completion of study drug - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterReichardt, , Robert Roessle Klinik
Universitaetsklinikum Essen *Recruiting*
ESSEN, , D-45122
Germany
Recruiting Contact Person 49-201-72311
Robert Roessle Klinik *Recruiting*
Berlin, , D-13122
Germany
Recruiting Contact Person 49-30-9417-1492
Medizinische Klinik I *Recruiting*
Dresden, , D-01307
Germany
Recruiting Contact Person 49-351-458-4790
Aarhus Kommunehospital *Recruiting*
Aarhus, , DK-8000
Denmark
Recruiting Contact Person 45-8612-5555
Cliniques Universitaires Saint-Luc *Recruiting*
Brussels, , 1200
Belgium
Recruiting Contact Person 32-2-764-1111
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-332-211
Universitaets-Krankenhaus Eppendorf *Recruiting*
Hamburg, , D-20246
Germany
Recruiting Contact Person 49-40-428-030
Medizinische Hochschule Hannover *Recruiting*
Hannover, , D-30625
Germany
Recruiting Contact Person 49-511-53240
Eberhard Karls Universitaet *Recruiting*
Tuebingen, , D-72076
Germany
Recruiting Contact Person 49-7071-292-711
National Cancer Institute - Bratislava *Recruiting*
Bratislava, , 833 10
Slovakia
Recruiting Contact Person 421-7-5937-8111
Additional Information:
Study ID Numbers: CDR0000069455; EORTC-62006
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041236
Other Uterine Sarcoma Studies:
1. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma
2. Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
3. Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma
4. Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
5. Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma
Related Studies:
Other uterine sarcoma Clinical Trials
Other Clinical Trials
Other Aarhus Clinical Trials
Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
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