Expired Study
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Cleveland, Ohio 44106


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 combination chemotherapy in treating patients who have advanced solid tumors.


Study summary:

OBJECTIVES: - Determine the pharmacokinetic profile of gemcitabine, doxorubicin HCl liposome, and vinorelbine in patients with advanced solid tumors. - Determine the maximum tolerated dose of this regimen in these patients. - Determine the toxicity profile of this regimen in these patients. OUTLINE: This is a dose escalation study. Patients receive doxorubicin HCl liposome IV over 1-2.5 hours on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and vinorelbine IV over 6-10 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome, gemcitabine, and vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed every 3 months for up to 1 year. PROJECTED ACCRUAL: Approximately 9-24 patients will be accrued for this study within 12-18 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor not amenable to curative surgery, radiotherapy, or chemotherapy - No brain metastases or primary brain tumors PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - WBC at least 3,500/mm3 - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin greater than 10 g/dL Hepatic: - Bilirubin no greater than 1.2 mg/dL - AST and/or ALT less than 2.5 times upper limit of normal (ULN) - PT no greater than ULN (anticoagulant independent) Renal: - Creatinine no greater than 1.5 mg/dL AND/OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No New York Heart Association class III or IV heart disease - LVEF at least 45% by MUGA or echocardiogram Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior bone marrow or peripheral blood stem cell transplantation following high dose chemotherapy - At least 3 weeks since prior biologic therapy for cancer and recovered - No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy: - See Disease Characteristics - See Biologic therapy - No more than 1 prior chemotherapy regimen - No prior vinca alkaloids - Prior anthracycline allowed if total dose no greater than 300 mg/m2 - At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or carmustine) and recovered Endocrine therapy: - At least 3 weeks since prior endocrine therapy for cancer and recovered Radiotherapy: - See Disease Characteristics - No more than 1 prior radiotherapy regimen - At least 4 weeks since prior large field radiotherapy - At least 3 weeks since prior radiotherapy for cancer and recovered Surgery: - Not specified


NCT ID:

NCT00006372


Primary Contact:

Study Chair
Beth A. Overmoyer, MD, FACP
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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