- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00009932
Combination Chemotherapy in Treating Patients With Solid Tumors
A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors
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 Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Ohio
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Gregory A. Otterson, MD, Ohio State University Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-00H0186
- CDR0000068425 (Registry Identifier: PDQ (Physician Data Query))
- NCI-2530
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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