Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
European Organization for Research and Treatment of Cancer |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003979 |
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: | 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.
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:
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 | |
U.Z. Gasthuisberg | |
Leuven, Belgium, B-3000 | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, B-2650 | |
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 Bergonie | |
Bordeaux, France, 33076 | |
Institut Claudius Regaud | |
Toulouse, France, 31052 | |
Institut Gustave Roussy | |
Villejuif, France, F-94805 | |
Germany | |
Klinikum Nuernberg - Klinikum Nord | |
Nuremberg, Germany, 90340 | |
Universitaetsklinik und Strahlenklinik - Essen | |
Essen, Germany, D-45122 | |
Netherlands | |
Academisch Ziekenhuis Groningen | |
Groningen, Netherlands, 9700 RB | |
Antoni van Leeuwenhoekhuis | |
Amsterdam, Netherlands, 1066 CX | |
Erasmus Medical Center | |
Rotterdam, Netherlands, 3075 EA | |
University Medical Center Nijmegen | |
Nijmegen, Netherlands, NL-6500 HB | |
Vrije Universiteit Medisch Centrum | |
Amsterdam, Netherlands, 1001HV | |
Norway | |
Norwegian Radium Hospital | |
Oslo, Norway, N-0310 | |
Switzerland | |
Inselspital, Bern | |
Bern, Switzerland, CH-3010 | |
Kantonsspital - St. Gallen | |
St. Gallen, Switzerland, CH-9007 | |
University Hospital | |
Basel, Switzerland, CH-4031 | |
United Kingdom, England | |
Newcastle General Hospital | |
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
United Kingdom, Scotland | |
Western General Hospital | |
Edinburgh, Scotland, United Kingdom, EH4 2XU | |
Ninewells Hospital and Medical School | |
Dundee, Scotland, United Kingdom, DD1 9SY | |
C.R.C. Beatson Laboratories | |
Glasgow, Scotland, United Kingdom, G61 1BD |
Study Chair: | Thomas Cerny, MD | Kantonsspital - St. Gallen |
Study ID Numbers: | CDR0000067183, EORTC-16985 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003979 |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |