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
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
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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