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 unresectable advanced or metastatic soft tissue sarcoma.

Condition	Treatment or Intervention	Phase
stage IVB adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage IVA adult soft tissue sarcoma stage III adult soft tissue sarcoma	Drug: ecteinascidin 743	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the rate of clinical benefit, in terms of the incidence of objective partial and complete response, stable disease, or minor response of more than 3 months duration, in patients with previously treated, unresectable advanced or metastatic soft tissue sarcoma treated with ecteinascidin 743. II. Determine the progression-free survival, overall survival, and response duration in patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Determine the pharmacokinetic-pharmacodynamic relationship of this drug in these patients.

PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to number of prior cytotoxic therapies for advanced disease (1-2 vs more than 2). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 36-76 patients (18-38 per stratum) will be accrued for this study within 13 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed advanced or metastatic soft tissue sarcoma; Unresectable disease
• Previously treated with at least 1 prior non-adjuvant chemotherapy regimen for advanced or metastatic disease; Adjuvant chemotherapy considered first-line treatment for advanced disease if the first relapse is less than 6 months after completion of therapy
• At least 1 bidimensionally measurable non-irradiated lesion; At least 20 mm in at least 1 diameter by CT scan; At least 20 by 20 mm for clinically measurable lesion
• No gastrointestinal stromal sarcoma
• No HIV-related Kaposi's sarcoma
• No malignant mesothelioma
• No chondrosarcomas
• No symptomatic brain or leptomeningeal involvement

--Prior/Concurrent Therapy--

• Biologic therapy: Recovered from prior immunotherapy; No concurrent prophylactic colony-stimulating factors (e.g., filgrastim (G- CSF) or sargramostim (GM-CSF)) during first course of study; No concurrent anticancer immunotherapy
• Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered; No other concurrent chemotherapy
• Endocrine therapy: No concurrent anticancer hormonal therapy
• Radiotherapy: See Disease Characteristics; Recovered from radiotherapy; No concurrent radiotherapy except palliative local radiotherapy
• Surgery: See Disease Characteristics
• Other: At least 30 days since prior investigational drugs; No other concurrent investigational or experimental anticancer drugs; No concurrent participation in other clinical trial

--Patient Characteristics--

• Age: 18 and over
• Performance status: WHO 0-2 OR Karnofsky 60-100%
• Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than upper limit of normal (ULN); Alkaline phosphatase no greater than ULN (unless suspected bone metastases present); AST/ALT less than 2.5 times ULN; Albumin at least 2.5 g/dL; No chronic active liver disease
• Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 40 mL/min
• Cardiovascular: No congestive heart failure; No angina pectoris, even if medically controlled; No myocardial infarction within the past year; No uncontrolled arterial hypertension or arrhythmias
• Other: No other neoplastic disease within the past 5 years except non-melanoma skin cancer or carcinoma in situ; No other serious illness or medical condition; No active infection; No history of significant neurological or psychiatric disorders; No symptomatic peripheral neuropathy grade 2 or greater; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 1 month after study

Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Robert Maki,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000068643; MSKCC-01018; NCI-G01-1948; PMAR-ET-B-022-00
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00017030
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08