MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Docetaxel; Dofequidar

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