MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors
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.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: docetaxel Drug: dofequidar fumarate||Phase 1|
|Study Design:||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 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004886
|Centre Oscar Lambret|
|Lille, France, 59020|
|Institut Curie - Section Medicale|
|Paris, France, 75248|
|Haemato-Onkologische Praxis und Tagesklinik|
|Munich (Muenchen), Germany, D-80639|
|Study Chair:||Veronique Dieras, MD||Institut Curie|