NCT00003981

E7070 in Treating Patients With Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 E7070 in treating patients who have solid tumors.

Detailed 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	indisulam

Timeline

• Start date: 1998-04-01
• First posted: 2003-01-27
• Last updated: 2012-07-11

Locations

26 sites across 9 countries: Austria, Belgium, Denmark, France, Germany, Netherlands, Norway, Switzerland, United Kingdom