E7070 in Treating Patients With Solid Tumors

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: indisulam	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	April 1998

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

Austria
Innsbruck Universitaetsklinik
Innsbruck, Austria, A-6020
Kaiser Franz Josef Hospital
Vienna, Austria, A-1100
Belgium
Institut Jules Bordet
Brussels, Belgium, B-1000
Ludwig Institute for Cancer Research
Brussels, Belgium, B-1200
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Denmark
Herlev Hospital - University Hospital of Copenhagen
Copenhagen, Denmark, DK-2730
France
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre Leon Berard
Lyon, France, 69373
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Institut Claudius Regaud
Toulouse, France, 31052
Institut Gustave Roussy
Villejuif, France, F-94805
Germany
Universitaetsklinikum Essen
Essen, Germany, D-45122
Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1001HV
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9700 RB
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Erasmus University Medical Center
Rotterdam, Netherlands, 3008 EA
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Switzerland
University Hospital
Basel, Switzerland, CH-4031
Inselspital, Bern
Bern, Switzerland, CH-3010
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
United Kingdom
Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom, DD1 9SY
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU

Sponsors and Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

Study Chair:	Axel R. Hanauske, MD, PhD, MBA	University Hospital, Gasthuisberg

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:	NCT00003981 History of Changes
Other Study ID Numbers:	EORTC-16975; EISAI-E7070-E044-103
First Posted:	January 27, 2003
Last Update Posted:	July 11, 2012
Last Verified:	July 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:

unspecified adult solid tumor, protocol specific