Clinical trial · Interventional
Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group
NCT00041236CI-TRIAL-00007480completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exatecan mesylate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTReichardt P, Nielsen OS, Bauer S, Hartmann JT, Schoffski P, Christensen TB, Pink D, Daugaard S, Marreaud S, Van Glabbeke M, Blay JY; EORTC Soft Tissue and Bone Sarcoma Group. Exatecan in pretreated adult patients with advanced soft tissue sarcoma: results of a phase II--study of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2007 Apr;43(6):1017-22. doi: 10.1016/j.ejca.2007.01.014. Epub 2007 Mar 1. PMID 17336054
- RESULTPink D, Reichardt P, Nielsen OS, et al.: Exatecan (DX-8951f), a new topoisomerase I - inhibitor, is inactive in heavily pretreated patients (pts.) with advanced soft tissue sarcoma (STS): a phase II study of the EORTC Soft Tissue and Bone Sarcoma Group. [Abstract] J Clin Oncol 23 (Suppl 16): A-9058, 830s, 2005.