Phase I Study to Determine the Safety of MS-209 in Combination With Docetaxel in Patients With a Solid Progressive Tumor
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Study to Determine the Safety of MS-209 in Combination With Docetaxel in Patients With a Solid Progressive Tumor
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Veronique Dieras, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Institut Curie
Authority:
United States: Federal Government
Study ID:
EORTC-16992
NCT ID:
NCT00004886
Start Date:
December 1999
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
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