Overview

E7070 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 E7070 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
Treatments:
N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide
Criteria
DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed solid tumor that is not amenable to standard
therapy

- 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/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL

Hepatic:

- Bilirubin less than 1.5 mg/dL

- Liver function tests no greater than 2.5 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 OR

- Creatinine clearance at least 60 mL/min

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No active bacterial infections (e.g., abscess or fistulae)

- No other nonmalignant disease that precludes protocol therapy

- No history of alcoholism, drug addiction, or psychotic disorders that preclude
participation

- No glaucoma

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

- No other concurrent antitumor drugs

Endocrine therapy:

- At least 4 weeks since prior anticancer hormonal therapy

Radiotherapy:

- At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy)

- No concurrent radiotherapy (except localized palliative radiotherapy)

Surgery:

- Not specified

Other:

- No concurrent sulfonylurea agent for diabetes or antiarrhythmic agents

- No other concurrent investigational drugs