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Home > "E" Clinical Trials Conditions > E7070 in Treating Patients With Solid Tumors  E7070 in Treating Patients With Solid Tumors
E7070 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 E7070 in treating patients who have solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of E7070 in patients with solid tumors. II. Assess the qualitative and quantitative toxicity in terms of predictability, duration, intensity, onset, reversibility, and dose relationship of this treatment regimen in this patient population. III. Determine a safe dose for phase II evaluation. IV. Assess the pharmacokinetics of this treatment regimen in these patients. V. Determine any possible antitumor activity of this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive E7070 IV over 1 hour once 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 E7070 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed solid tumor not amenable to standard therapy - No brain tumor 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: 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 for localized palliation - Surgery: Not specified - Other: No other concurrent investigational drugs or antitumor drugs; No sulphonylureas or anti-arrhythmic agents --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/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin less than 1.5 mg/dL; Transaminases and alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN for liver metastases) - Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance at least 60 mL/min - Other: No active bacterial infections (e.g., abscess or fistula); No other nonmalignant disease that precludes protocol therapy; No history of alcoholism, drug addiction, or psychotic disorders that would prevent compliance; No glaucoma; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeanArmand, Study Chair, EORTC Early Clinical Studies Group
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Innsbruck Universitaetsklinik
Innsbruck, , A-6020
Austria
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, , 1117 MB
Netherlands
Herlev Hospital - University Hospital of Copenhagen
Herlev, , DK-2730
Denmark
Institut Jules Bordet
Brussels, , 1000
Belgium
Kantonsspital - Saint Gallen
Saint Gallen, , CH-9007
Switzerland
Ludwig Institute for Cancer Research-Brussels Branch
Brussels, , B-1200
Belgium
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Inselspital, Bern
Bern, , CH-3010
Switzerland
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
United Kingdom
C.R.C. Beatson Laboratories
Glasgow, Scotland, G61 1BD
United Kingdom
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
United Kingdom
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Kaiser Franz Josef Hospital
Vienna, , A-1100
Austria
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
University Medical Center Nijmegen
Nijmegen, , NL-6252 HB
Netherlands
University Hospital
Basel, , CH-4031
Switzerland
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Klinikum Nurnberg
Nuremberg (Nurnberg), , D-90419
Germany
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Centre Leon Berard
Lyon, , 69373
France
Institut Claudius Regaud
Toulouse, , 31052
France
Institut Gustave Roussy
Villejuif, , F-94805
France
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
Universitaetsklinik und Strahlenklinik - Essen
ESSEN, , D-45122
Germany
Additional Information:
Study ID Numbers: CDR0000067179; EORTC-16973,EISAI-E7070-E044-101
Study Start Date: March 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003976
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. SU5416 and Paclitaxel in Treating Patients With Advanced Cancer
2. Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain
3. Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors
4. Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
5. GW786034 in Treating Patients With Advanced Solid Tumors
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E7070 in Treating Patients With Solid Tumors
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