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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003979 |
Purpose
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 CHS 828 in treating patients who have solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: CHS 828 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks |
| Estimated Enrollment: | 30 |
| Study Start Date: | April 1999 |
OBJECTIVES:
OUTLINE: Patients receive oral CHS 828 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 CHS 828 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.
Patients are followed for up to 4 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and 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 | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| 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 | |
| Universitaetsklinik und Strahlenklinik - Essen | |
| Essen, Germany, D-45122 | |
| Klinikum Nuernberg - Klinikum Nord | |
| Nuremberg, Germany, 90340 | |
| 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 Medical Center | |
| Rotterdam, Netherlands, 3075 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 | |
| Ninewells Hospital and Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| C.R.C. Beatson Laboratories | |
| Glasgow, Scotland, United Kingdom, G61 1BD | |
| Study Chair: | Thomas Cerny, MD | Kantonsspital - St. Gallen |
More Information
| ClinicalTrials.gov Identifier: | NCT00003979 History of Changes |
| Other Study ID Numbers: | CDR0000067183, EORTC-16985 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 17, 2009 |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific |
|
Neoplasms |