E7070 in Treating Patients With Solid Tumors
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| ClinicalTrials.gov Identifier: NCT00003981 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : July 11, 2012
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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 |
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 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 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003981
| 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 | |
| Study Chair: | Axel R. Hanauske, MD, PhD, MBA | University Hospital, Gasthuisberg |
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00003981 History of Changes |
| Other Study ID Numbers: |
EORTC-16975 EORTC-16975 EISAI-E7070-E044-103 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | July 11, 2012 |
| Last Verified: | July 2012 |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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unspecified adult solid tumor, protocol specific |