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Trial NCT00041236

Resource URI: http://static.linkedct.org/resource/trials/NCT00041236
linkedct:brief_title Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
linkedct:condition <http://static.linkedct.org/resource/condition/11745>
linkedct: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
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 15 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date July 8, 2002
linkedct:id NCT00041236
rdfs:label Trial NCT00041236
linkedct:lastchanged_date July 23, 2008
linkedct:lead_sponsor_agency European Organization for Research and Treatment of Cancer
linkedct:location <http://static.linkedct.org/resource/location/10538>
linkedct:location <http://static.linkedct.org/resource/location/111025>
linkedct:location <http://static.linkedct.org/resource/location/30931>
linkedct:location <http://static.linkedct.org/resource/location/65845>
linkedct:location <http://static.linkedct.org/resource/location/66013>
linkedct:location <http://static.linkedct.org/resource/location/66129>
linkedct:location <http://static.linkedct.org/resource/location/66268>
linkedct:location <http://static.linkedct.org/resource/location/66486>
linkedct:location <http://static.linkedct.org/resource/location/66931>
linkedct:location <http://static.linkedct.org/resource/location/9246>
linkedct:nct_id NCT00041236
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct: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
linkedct:org_study_id CDR0000069455
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/46928>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00041236>
linkedct:phase Phase 2
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/1400>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/7007>
linkedct:secondary_id EORTC-62006
linkedct:source National Cancer Institute (NCI)
linkedct:start_date May 2002
linkedct:study_design Treatment, Open Label
linkedct:study_type Interventional
linkedct: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 exatecan mesylate in treating patients who have advanced soft tissue sarcoma.
rdf:type linkedct:trials
linkedct:verification_date February 2005