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Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor as a Single IV Infusion Weekly X 4, Repeated Every 6 Weeks


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor as a Single IV Infusion Weekly X 4, Repeated Every 6 Weeks


OBJECTIVES:

- Determine the maximum tolerated dose (MTD) of E7070 when administered to adult patients
with solid tumors.

- Determine the qualitative and quantitative toxic effects of this drug and study the
predictability, duration, intensity, onset, reversibility and dose relationship of the
toxic effects in this patient population.

- Propose a safe dose for phase II study.

- Assess the pharmacokinetics of this drug at different dose levels in this patient
population.

- Determine any possible antitumor activity of this drug in this patient population.

OUTLINE: This is a dose escalation study.

Patients receive E7070 IV over 1 hour on days 1, 8, 15, and 22. Treatment continues every 6
weeks for at least 2 courses in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of E7070 is escalated until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose limiting toxicity.

Patients are followed every 3 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Axel R. Hanauske, MD, PhD, MBA

Investigator Role:

Study Chair

Investigator Affiliation:

U.Z. Gasthuisberg

Authority:

United States: Federal Government

Study ID:

EORTC-16975

NCT ID:

NCT00003981

Start Date:

April 1998

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

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