Overview

MEN-10755 in Treating Patients With 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 MEN-10755 in treating patients who have solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor that is not
amenable to standard therapy Measurable or evaluable disease No brain involvement or
leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Liver function tests no
greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver
metastases present) Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at
least 60 mL/min Cardiovascular: LVEF at least 50% (by MUGA) Other: Not pregnant or nursing
Fertile patients must use effective contraception No active infections No other
nonmalignant disease that precludes study No history of alcoholism, drug addiction, or
psychotic disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy
Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas,
mitomycin, and high dose carboplatin) No other concurrent antitumor drugs Endocrine
therapy: No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior
radiotherapy (6 weeks for extensive radiotherapy) No concurrent radiotherapy Surgery: Not
specified Other: No prior anthracyclines or anthracenediones No other concurrent
investigational drugs