Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor on a Single IV Infusion Repeated Every 3 Weeks
18 Years
70 Years
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor on a Single IV Infusion Repeated Every 3 Weeks
OBJECTIVES: I. Determine the maximum tolerated dose of E7070 in patients with solid tumors.
II. Assess the qualitative and quantitative toxicity in terms of predictability, duration,
intensity, onset, reversibility, and dose relationship of this treatment regimen in this
patient population. III. Determine a safe dose for phase II evaluation. IV. Assess the
pharmacokinetics of this treatment regimen in these patients. V. Determine any possible
antitumor activity of this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive E7070 IV over 1 hour once every 3
weeks. Treatment continues for at least 2 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of E7070 until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which at least 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 12
months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor not
amenable to standard therapy No brain tumor involvement or leptomeningeal disease
PATIENT CHARACTERISTICS: Age: 18 to 70 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 Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 1.5 mg/dL
Transaminases and alkaline phosphatase no greater than 2.5 times upper limit of normal
(ULN) (no greater than 5 times ULN for liver metastases) Renal: Creatinine no greater than
1.4 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active bacterial infections
(e.g., abscess or fistula) No other nonmalignant disease that precludes protocol therapy
No history of alcoholism, drug addiction, or psychotic disorders that would prevent
compliance No glaucoma Not pregnant or nursing Fertile patients must use effective
contraception
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: 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 for localized palliation Surgery: Not specified Other: No
other concurrent investigational drugs or antitumor drugs No sulphonylureas or
anti-arrhythmic agents
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Jean-Pierre Armand, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
United States: Federal Government
Study ID:
EORTC-16973
NCT ID:
NCT00003976
Start Date:
March 1998
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
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