MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors

NCT00004886 | Completed Phase 1

• 1 other identifier: EORTC-16992
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

docetaxel DRUG

dofequidar fumarate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (3)

Centre Oscar Lambret

Lille, 59020, France

Location

Institut Curie - Section Medicale

Paris, 75248, France

Location

Haemato-Onkologische Praxis und Tagesklinik

Munich (Muenchen), D-80639, Germany

Location

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Veronique Dieras, MD

  Institut Curie

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: October 1, 2003
• Study Start: December 1, 1999
• Primary Completion: June 1, 2002
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

DE (1); FR (2)