Overview

BIBX 1382 in Treating Patients With Solid Tumors

Status:
Suspended

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 BIBX 1382 in treating patients who have solid tumors.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven solid tumor not amenable to
standard treatment No symptomatic 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 2,000/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Other liver function tests no
greater than 2 times upper limit of normal (unless related to liver metastases) Renal:
Creatinine no greater than 1.4 mg/dL Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study No
active bacterial infections No nonmalignant disease that would be incompatible with study
No prior 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)
Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy (6
weeks for extensive radiotherapy) No concurrent radiotherapy Surgery: Not specified Other:
No other concurrent investigational or antitumor drugs