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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-16975 | |||
| EISAI-E7070-E044-103 |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indisulam | Drug |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Axel R. Hanauske, MD, PhD, MBA | University Hospital, Gasthuisberg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck Universitaetsklinik | Innsbruck | A-6020 | Austria | |||
| Kaiser Franz Josef Hospital |
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| Vienna |
| A-1100 |
| Austria |
| Institut Jules Bordet | Brussels | B-1000 | Belgium |
| Ludwig Institute for Cancer Research | Brussels | B-1200 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | B-2650 | Belgium |
| U.Z. Gasthuisberg | Leuven | B-3000 | Belgium |
| Herlev Hospital - University Hospital of Copenhagen | Copenhagen | DK-2730 | Denmark |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| CRLCC Nantes - Atlantique | Nantes-Saint Herblain | 44805 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| Universitaetsklinikum Essen | Essen | D-45122 | Germany |
| Vrije Universiteit Medisch Centrum | Amsterdam | 1001HV | Netherlands |
| Antoni van Leeuwenhoekhuis | Amsterdam | 1066 CX | Netherlands |
| Academisch Ziekenhuis Groningen | Groningen | 9700 RB | Netherlands |
| University Medical Center Nijmegen | Nijmegen | NL-6500 HB | Netherlands |
| Erasmus University Medical Center | Rotterdam | 3008 EA | Netherlands |
| Norwegian Radium Hospital | Oslo | N-0310 | Norway |
| University Hospital | Basel | CH-4031 | Switzerland |
| Inselspital, Bern | Bern | CH-3010 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| Newcastle General Hospital | Newcastle upon Tyne | England | NE4 6BE | United Kingdom |
| Royal Marsden Hospital | Sutton | England | SM2 5PT | United Kingdom |
| Ninewells Hospital and Medical School | Dundee | Scotland | DD1 9SY | United Kingdom |
| Western General Hospital | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| ID | Term |
|---|---|
| C439829 | N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide |
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