E7070 in Treating Patients With Solid Tumors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor on a Single IV Infusion Repeated Every 3 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003976
• Other study ID #: EORTC-16973
• Secondary ID: EORTC-16973EISAI
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: July 10, 2012
• Start date: March 1998

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• indisulam

Locations

Country	Name	City	State
Austria	Innsbruck Universitaetsklinik	Innsbruck
Austria	Kaiser Franz Josef Hospital	Vienna
Belgium	Institut Jules Bordet	Brussels
Belgium	Ludwig Institute for Cancer Research-Brussels Branch	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	U.Z. Gasthuisberg	Leuven
Denmark	Herlev Hospital - University Hospital of Copenhagen	Herlev
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Leon Berard	Lyon
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	Institut Claudius Regaud	Toulouse
France	Institut Gustave Roussy	Villejuif
Germany	Universitaetsklinik und Strahlenklinik - Essen	Essen
Germany	Klinikum Nurnberg	Nuremberg (Nurnberg)
Netherlands	Academisch Ziekenhuis der Vrije Universiteit	Amsterdam
Netherlands	Antoni van Leeuwenhoekhuis	Amsterdam
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Rotterdam Cancer Institute	Rotterdam
Norway	Norwegian Radium Hospital	Oslo
Switzerland	University Hospital	Basel
Switzerland	Inselspital, Bern	Bern
Switzerland	Kantonsspital - Saint Gallen	Saint Gallen
United Kingdom	Ninewells Hospital and Medical School	Dundee	Scotland
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	C.R.C. Beatson Laboratories	Glasgow	Scotland
United Kingdom	Newcastle General Hospital	Newcastle Upon Tyne	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  Netherlands,  Norway,  Switzerland,  United Kingdom,