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MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors - Article


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Docetaxel

Taxotere



Clinical Trial: MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors

This study is no longer recruiting patients.

Sponsored by: EORTC New Drug Development Group
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
unspecified adult solid tumor, protocol specific
 Procedure: chemotherapy
 Drug: docetaxel
 Drug: MS-209
Phase I

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of MS-209 Plus Docetaxel in Patients With Advanced Solid Malignant Tumors

Further Study Details: 

Study start: December 1999

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

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

Location Information


France
      Centre Oscar Lambret, Lille,  59020,  France

      Institut Curie - Section Medicale, Paris,  75248,  France

Germany
      Haemato-Onkologische Praxis und Tagesklinik, Munich (Muenchen),  D-80639,  Germany

Study chairs or principal investigators

Veronique Dieras,  Study Chair,  EORTC New Drug Development Group   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067561; EORTC-16992
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004886
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: October 3, 2005
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