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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Solid Tumors  Combination Chemotherapy in Treating Patients With Solid Tumors
Combination Chemotherapy in Treating Patients With Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Determine the pharmacokinetics of this regimen in these patients. III. Determine the therapeutic response to this regimen in these patients. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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) --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 --Patient Characteristics-- Age: 18 and over Performance status: - ECOG 0-2 OR - Zubrod 0-2 Life expectancy: Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GregoryOtterson, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Additional Information:
Study ID Numbers: CDR0000068425; OSU-00H0186,NCI-2530
Study Start Date: January 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009932
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Vaccine Therapy in Treating Patients With Advanced Cancer
2. VNP20009 in Treating Patients With Advanced Solid Tumors
3. Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
4. Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
5. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Combination Chemotherapy in Treating Patients With Solid Tumors
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