A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Gregory A. Otterson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ohio State University Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
OSU-00H0186
NCT ID:
NCT00009932
Start Date:
January 2001
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
