Trial | NCT00004886  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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.
Study Started
Dec 31
1999
Primary Completion
Jun 30
2002
Last Update
Sep 24
2012
Estimate

Drug docetaxel

Drug dofequidar fumarate

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
No Results Posted