Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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 E7389 in treating patients who have advanced solid tumors.

Further Study Information

OBJECTIVES:

• Determine the maximum tolerated dose of E7389 in patients with advanced solid tumors.

• Determine the toxic effects of this drug in these patients.

• Determine the pharmacokinetics of this drug in these patients.

• Determine the in vivo anti-mitotic activity of this drug before and after treatment in these patients.

• Determine, preliminarily, the target validation feasibility of this drug in patients with biopsy-accessible tumor.

• Determine the clinical response in patients treated with this drug.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive E7389 IV over 1-2 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of E7389 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

Additional patients with biopsy-accessible tumors are accrued and treated as above at the MTD.

PROJECTED ACCRUAL: Approximately 31 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor refractory to standard therapy or for which no standard therapy exists

• Tumors must be accessible for repeated biopsy in patients in the expanded cohort (at the maximum tolerated dose)

• Evaluable disease

• Pleural effusions, ascites, and bone metastases are evaluable

• No brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• At least 2 months

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

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

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• SGOT and SGPT no greater than 2.5 times upper limit of normal

Renal

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No poorly controlled cardiovascular disease

• No severe cardiovascular disease that would preclude study

Pulmonary

• No poorly controlled pulmonary disease

• No severe pulmonary disease that would preclude study

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No poorly controlled CNS disease

• No severe CNS disease that would preclude study

• No other poorly controlled nonmalignant disease

• No other severe nonmalignant disease that would preclude study

• No active severe infection requiring therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and 8 weeks for UCN-01) and recovered

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Recovered from prior major surgery

Other

• No concurrent antiretroviral medications for HIV-positive patients

• No other concurrent investigational drugs

• No other concurrent antineoplastic therapy

Trial Contact Information

Trial Lead Organizations/Sponsors

California Cancer Consortium

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00047034
Information obtained from ClinicalTrials.gov on December 14, 2011

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