|
BIBX 1382 in Treating Patients With Solid Tumors Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about BIBX 1382 in Treating Patients With Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. BIBX 1382 in Treating Patients With Solid Tumors Clinical research trials and BIBX 1382 in Treating Patients With Solid Tumors medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as BIBX 1382 in Treating Patients With Solid Tumors. BIBX 1382 in Treating Patients With Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a BIBX 1382 in Treating Patients With Solid Tumors clinical trial. Participants frequently get the best healthcare available for their BIBX 1382 in Treating Patients With Solid Tumors condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > BIBX 1382 in Treating Patients With Solid Tumors  BIBX 1382 in Treating Patients With Solid Tumors
BIBX 1382 in Treating Patients With Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): EORTC Early Clinical Studies Group ,
Synopsis: 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 BIBX 1382 in treating patients who have solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of oral BIBX 1382 in patients with solid tumors. II. Determine qualitative and quantitative toxicities of oral BIBX 1382 in these patients. III. Determine predictability, duration, intensity, onset, reversibility, and dose relationship of the toxicities of oral BIBX 1382 in these patients. IV. Determine safe and optimal doses of oral BIBX 1382 for a Phase II study. V. Assess the pharmacokinetics of oral BIBX 1382 in these patients. VI. Document any antitumor activity in these patients treated with oral BIBX 1382. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive BIBX 1382 IV over 1 hour followed 7 days later by oral BIBX 1382. Beginning 3 days later, patients receive oral BIBX 1382 daily for 28 days. Courses of daily oral BIBX 1382 repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oral BIBX 1382. The maximum tolerated dose (MTD) is defined as the dose at which dose limiting toxicity occurs in at least 2 of 6 patients. Patients are followed for up to 4 weeks. PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study over 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven solid tumor not amenable to standard treatment - No symptomatic brain involvement or leptomeningeal disease --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy); No concurrent radiotherapy - Surgery: Not specified - Other: No other concurrent investigational or antitumor drugs --Patient Characteristics-- - Age: 18 and over - Performance status: WHO 0-2 - Life expectancy: At least 3 months - Hematopoietic: Absolute neutrophil count at least 2,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 1.5 mg/dL; Other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases) - Renal: Creatinine no greater than 1.4 mg/dL - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after study; No active bacterial infections; No nonmalignant disease that would be incompatible with study; No prior alcoholism, drug addiction, or psychotic disorders
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristianDittrich, Study Chair, EORTC Early Clinical Studies Group
Universitaetsklinik und Strahlenklinik - Essen
ESSEN, , D-45122
Germany
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
United Kingdom
Innsbruck Universitaetsklinik
Innsbruck, , A-6020
Austria
University Medical Center Nijmegen
Nijmegen, , NL-6252 HB
Netherlands
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
Inselspital, Bern
Bern, , CH-3010
Switzerland
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
C.R.C. Beatson Laboratories
Glasgow, Scotland, G61 1BD
United Kingdom
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, , 1117 MB
Netherlands
Ludwig Institute for Cancer Research-Brussels Branch
Brussels, , B-1200
Belgium
Herlev Hospital - University Hospital of Copenhagen
Herlev, , DK-2730
Denmark
Kantonsspital - Saint Gallen
Saint Gallen, , CH-9007
Switzerland
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Institut Jules Bordet
Brussels, , 1000
Belgium
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
United Kingdom
Institut Gustave Roussy
Villejuif, , F-94805
France
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Centre Leon Berard
Lyon, , 69373
France
Klinikum Nurnberg
Nuremberg (Nurnberg), , D-90419
Germany
University Hospital
Basel, , CH-4031
Switzerland
Kaiser Franz Josef Hospital
Vienna, , A-1100
Austria
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Institut Claudius Regaud
Toulouse, , 31052
France
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Additional Information:
Study ID Numbers: CDR0000067184; EORTC-16981
Study Start Date: February 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003980
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Creatine in Treating Patients With Cancer-Associated Weight Loss
2. KRN7000 in Treating Patients With Solid Tumors
3. Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
4. Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors
5. Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Scotland Clinical Trials
Other Glasgow Clinical Trials
BIBX 1382 in Treating Patients With Solid Tumors
|
|
|
|
|
|
|
|
