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MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Study NCT00004886   Information provided by National Cancer Institute (NCI)
First Received: March 7, 2000   Last Updated: July 23, 2008   History of Changes

March 7, 2000
July 23, 2008
December 1999
 
 
 
Complete list of historical versions of study NCT00004886 on ClinicalTrials.gov Archive Site
 
 
 
MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors
Phase I Study to Determine the Safety of MS-209 in Combination With Docetaxel in Patients With a Solid Progressive Tumor

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.

OBJECTIVES:

  • Determine the maximum tolerated dose of oral MS-209 when given with docetaxel IV in patients with advanced solid malignant tumors.
  • Assess the toxicity of this regimen in these patients.

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.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: MS-209
  • Drug: docetaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced malignant solid tumor

    • No gastric cancer
  • No brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • 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

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT00004886
 
CDR0000067561, EORTC-16992
European Organization for Research and Treatment of Cancer
 
Study Chair: Veronique Dieras, MD Institut Curie Hopital
National Cancer Institute (NCI)
September 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP