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MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors Clinical research trials and MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors. MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors clinical trial. Subjects frequently get the best healthcare possible for their MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors  MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors
MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): EORTC New Drug Development Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of MS 209 plus docetaxel in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of oral MS-209 when given with docetaxel IV in patients with advanced solid malignant tumors. II. Assess the toxicity of this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation, multicenter study of MS-209. Patients receive docetaxel IV over 1 hour on day 1 of a 3 week course. On day 1 of the 2nd course, patients receive MS-209 orally followed by docetaxel IV over 1 hour. Treatment is repeated every 3 weeks for 4-7 courses (including course with docetaxel alone). Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of MS-209 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients experience dose limiting toxicities. Patients are followed every 6 weeks. PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced malignant solid tumor; No gastric cancer - No 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); No prior docetaxel; No other concurrent chemotherapy - Endocrine therapy: At least 4 weeks since prior hormonal therapy - Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks if extensive) - Surgery: Not specified - Other: No other concurrent anticancer drugs; No other concurrent investigational therapies; No H2-blockers, proton pump inhibitors, sucralfate or any other drug that would impair absorption; No concurrent drugs exhibiting liver, kidney, heart or lung toxicity; No concurrent MDR-modulating drugs (e.g., calcium antagonists, immunosuppressives); No concurrent antifungals (ketoconazole, fluconazole) or antibiotics (clarithromycin, erthromycin) that interfere with MS-209 metabolism --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: Neutrophil count at least 2,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 11.2 g/dL - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST and ALT no greater than 2.5 times ULN; Alkaline phosphatase no greater than 2.5 times ULN - Renal: Creatinine no greater than 1.4 mg/dL - Cardiovascular: Normal cardiac function; Left ventricular ejection fraction normal - Other: No digestive disease that hampers absorption; No unstable systemic disease or uncontrolled infection that precludes study; No psychological, familial, sociological, or geographical condition that precludes compliance; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
VeroniqueDieras, Study Chair, EORTC New Drug Development Group
Institut Curie - Section Medicale
Paris, , 75248
France
Haemato-Onkologische Praxis und Tagesklinik
Munich (Muenchen), , D-80639
Germany
Centre Oscar Lambret
Lille, , 59020
France
Additional Information:
Study ID Numbers: CDR0000067561; EORTC-16992
Study Start Date: December 1999
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004886
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Creatine in Treating Patients With Cancer-Associated Weight Loss
2. R115777 in Treating Patients With Advanced Solid Tumors
3. SU5416 in Treating Patients With Advanced Solid Tumors
4. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
5. Gemcitabine Plus Flavopiridol in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
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MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors
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