E7070 in Treating Patients With Solid Tumors

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: indisulam

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00003981

EISAI-E7070-E044-103

EORTC-16975

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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