Expired Study
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Columbus, Ohio 43210


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 combining fenretinide, paclitaxel, and cisplatin in treating patients who have solid tumors that have not responded to previous therapy.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose, clinical toxicity, and recommended phase II dose of fenretinide when combined with paclitaxel and cisplatin in patients with refractory solid tumors. - Determine the pharmacokinetics of this regimen in these patients. - Determine the therapeutic response to this regimen in these patients. OUTLINE: This is a dose escalation, multicenter study of fenretinide. Patients receive oral fenretinide twice daily on days 1-7 and paclitaxel IV over 3 hours followed by cisplatin IV over 2 hours on day 2. On day 8 of course 1, patients also receive fenretinide once in the morning. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses. Cohorts of 3-6 patients receive escalating doses of fenretinide 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. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1 year.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically proven refractory solid tumor for which paclitaxel and cisplatin are reasonable therapeutic options - No active CNS disease - CNS metastasis allowed if measurable disease outside of the CNS and patient completed and recovered from 1 prior course of CNS radiotherapy (if clinically indicated) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Platelet count at least 100,000/mm3 - Absolute neutrophil count at least 1,500/mm3 Hepatic: - Bilirubin no greater than 2.0 mg/dL - ALT and AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if related to liver metastases) Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No severe symptomatic cardiac disease Other: - No clinically significant/evident retinopathy - No other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ of the cervix - No uncontrolled infection - No other significant medical or psychiatric condition that would increase risk - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for 1 month before, during, and for at least 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - No prior paclitaxel, cisplatin, or fenretinide - At least 4 weeks since other prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy to only site of measurable/evaluable disease - No prior radiotherapy to more than 25% of bone marrow Surgery: - At least 2 weeks since prior therapeutic surgery and recovered Other: - At least 4 weeks since prior routine vitamin A of at least 10,000 IU/ day or beta carotene of at least 10 mg/day


NCT ID:

NCT00009932


Primary Contact:

Study Chair
Gregory A. Otterson, MD
Ohio State University Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
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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