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: This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with advanced solid tumors.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of the combination of fenretinide, paclitaxel, and cisplatin in patients with advanced solid tumors. - Determine the effect of fenretinide on the pharmacokinetics of paclitaxel and cisplatin. - Assess the relationship between dose or plasma levels of fenretinide and the safety and antitumor effects, in terms of overall response, response rate, and progression-free survival rate, in these patients. OUTLINE: This is a dose-escalation study of paclitaxel and cisplatin. Patients receive oral fenretinide twice daily for 7 days. Patients receive paclitaxel IV over 3 hours and cisplatin IV over 30 minutes on day 7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin 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. Once the MTD is determined, additional patients are accrued to receive paclitaxel and cisplatin at the recommended phase II dose. PROJECTED ACCRUAL: Approximately 15-24 patients will be accrued for this study within 12-24 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed advanced solid tumor not amenable to conventional surgery, radiotherapy, or chemotherapy - No brain metastases or primary brain tumors PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - At least 12 weeks Hematopoietic: - WBC at least 3,500/mm^3 - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin greater than 9.0 g/dL Hepatic: - Bilirubin less than 1.6 mg/dL - AST and ALT less than 2 times upper limit of normal - PT and PTT normal OR - INR less than 1.1 Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No extensive signs of macular degeneration, including exudative or atrophic macular lesions reducing corrected vision to less than 20/40 PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - Prior platinum-containing agents and taxane exposure allowed with no evidence of neurotoxicity Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - No concurrent vitamin A supplements - No concurrent supplemental antioxidants


NCT ID:

NCT00005819


Primary Contact:

Principal Investigator
Scot C. Remick, MD
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 19, 2017

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