MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004886
Recruitment Status : Completed
First Posted : October 1, 2003
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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 or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: docetaxel Drug: dofequidar fumarate Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Primary Purpose: Treatment
Official Title: Phase I Study to Determine the Safety of MS-209 in Combination With Docetaxel in Patients With a Solid Progressive Tumor
Study Start Date : December 1999
Primary Completion Date : June 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed advanced malignant solid tumor

    • No gastric cancer
  • No brain involvement or leptomeningeal disease



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


  • Neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 11.2 g/dL


  • 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


  • Creatinine no greater than 1.4 mg/dL


  • Normal cardiac function
  • Left ventricular ejection fraction normal


  • 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


Biologic therapy:

  • At least 4 weeks since prior immunotherapy


  • 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


  • At least 4 weeks since prior radiotherapy (6 weeks if extensive)


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004886

Centre Oscar Lambret
Lille, France, 59020
Institut Curie - Section Medicale
Paris, France, 75248
Haemato-Onkologische Praxis und Tagesklinik
Munich (Muenchen), Germany, D-80639
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Veronique Dieras, MD Institut Curie

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00004886     History of Changes
Other Study ID Numbers: EORTC-16992
First Posted: October 1, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action