Overview

Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors

Status:
Completed
Trial end date:
1969-12-31
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 I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Treatments:
Trabectedin
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor that is not
amenable to standard therapy No evidence of brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: ANC at least 2,000/mm3 Platelet count at least 100,000/mm3
Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 mg/dL Transaminases normal (no
greater than 2.5 times normal if liver metastases) Alkaline phosphatase normal (no greater
than 2.5 times normal if liver or bone metastases) No history of chronic liver disease,
e.g., chronic active hepatitis, cirrhosis Renal: Creatinine no greater than 1.4 mg/dL
Creatinine clearance at least 60 mL/min Other: No active bacterial infection (e.g.,
abscess) or with fistulae No grade 2 or worse neurotoxicity No concurrent medical condition
that precludes treatment No history of alcoholism, drug addiction, or psychotic disorder
Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Colony-stimulating factors allowed for specific
indications At least 4 weeks since prior biologic therapy, immunotherapy, or growth factors
Chemotherapy: No prior intensive chemotherapy with bone marrow or stem cell support At
least 4 weeks since chemotherapy (6 weeks since nitrosoureas, mitomycin, or high-dose
carboplatin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since
radiotherapy Concomitant palliative local radiotherapy allowed for existing lesion Surgery:
Recovered from prior surgery Other: No concurrent investigational drug Concurrent
prophylactic antiemetics allowed after first therapy course