Docetaxel |
Taxotere |
Clinical Trial: MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors
This study is no longer recruiting patients.
Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| unspecified adult solid tumor, protocol specific | Procedure: chemotherapy Drug: docetaxel Drug: MS-209 | Phase I |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of MS-209 Plus Docetaxel in Patients With Advanced Solid Malignant Tumors
Study start: December 1999
OBJECTIVES: I. Determine the maximum tolerated dose of oral MS-209 when given with docetaxel IV in patients with advanced solid malignant tumors. II. Assess the toxicity of this regimen in these patients.
PROTOCOL 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.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically confirmed advanced malignant solid tumor; No gastric cancer
- No brain involvement or leptomeningeal disease
--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
--Patient Characteristics--
- Age: 18 and over
- Performance status: ECOG 0-2
- Life expectancy: At least 3 months
- Hematopoietic: Neutrophil count at least 2,000/mm3; Platelet count at least 100,000/mm3; 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
Location Information
France
Centre Oscar Lambret, Lille, 59020, France
Institut Curie - Section Medicale, Paris, 75248, France
Germany
Haemato-Onkologische Praxis und Tagesklinik, Munich (Muenchen), D-80639, Germany
Veronique Dieras, Study Chair, EORTC New Drug Development Group
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: September 2003
Last Updated: October 13, 2004
Record first received: March 7, 2000
ClinicalTrials.gov Identifier: NCT00004886
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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