Phase I Study to Determine the Safety of MS-209 in Combination With Docetaxel in Patients With a Solid Progressive Tumor


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

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

Name

Location