Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma

• Status: Terminated
• Trial end date: 2002-02-01
• Target enrollment: 0
• Participant gender: All

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 ecteinascidin 743 in treating patients who have malignant mesothelioma that cannot be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaMar
• Collaborator: National Cancer Institute (NCI)
• Treatments: Trabectedin

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignant mesothelioma that is not amenable to curative surgery At least 1 unidimensionally measurable lesion that is at least 15 mm by CT scan OR At least 1 bidimensionally measurable lesion that is at least 10 mm by CT scan Lesions in previously irradiated area are not considered measurable unless there is evidence of progression No symptomatic brain or leptomeningeal involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 OR Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than ULN unless bone metastases are present AST/ALT no greater than 2.5 times ULN Albumin at least 2.5 g/dL No chronic active liver disease Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No uncontrolled heart disease No uncontrolled hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for one month after study No other serious illness or medical condition No history of significant neurological or psychiatric disorders No significant active infection No other concurrent neoplastic disease except non-melanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prophylactic hematopoietic colony-stimulating factors (e.g., filgrastim (G-CSF) or sargramostim (GM-CSF)) Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: See Disease Characteristics At least 30 days since prior radiotherapy and recovered No concurrent radiotherapy except palliative local radiotherapy to non-target lesions Surgery: See Disease Characteristics At least 14 days since prior pleurodesis Recovered from prior surgery Other: At least 30 days since prior participation in another therapeutic clinical trial or therapy with other investigational drugs No concurrent treatment for other neoplastic disease No other concurrent experimental anticancer medication