Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

E7389 in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI CCC-PHI-39 CHNMC-PHI-39, NCI-5730, NCT00047034, 5730

Objectives

1. Determine the maximum tolerated dose of E7389 in patients with advanced solid tumors.
2. Determine the toxic effects of this drug in these patients.
3. Determine the pharmacokinetics of this drug in these patients.
4. Determine the in vivo anti-mitotic activity of this drug before and after treatment in these patients.
5. Determine, preliminarily, the target validation feasibility of this drug in patients with biopsy-accessible tumor.
6. Determine the clinical response in patients treated with this drug.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

Approximately 31 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

California Cancer Consortium

Clinical Trials Office - New Patient Services		Ph: 800-826-4673 Email: becomingapatient@coh.org

Registry Information
Official Title		Phase I Trial Of E7389 (Halichondrin B Analog) (NSC# 707389) In Patients With Advanced Solid Tumors
Trial Start Date		2002-09-01
Registered in ClinicalTrials.gov		NCT00047034
Date Submitted to PDQ		2002-08-08
Information Last Verified		2005-03-01
NCI Grant/Contract Number		CA33572, CA62505

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