Head and Neck Cancer Clinical Trial
Official title:
A Phase IB Randomized Translational Study of Fenretinide (4-HPR) in Combination With SCH66336, a Farnesyl Transferase Inhibitor, in Patients With Advanced or Recurrent Head and Neck Cancer
RATIONALE: Drugs, such as fenretinide and lonafarnib, may stop the growth of head and neck
cancer by blocking blood flow to the tumor. Fenretinide may also help tumor cells become
normal cells. Lonafarnib may also stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Giving fenretinide together with lonafarnib may kill more
tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of
fenretinide and lonafarnib in treating patients with advanced or recurrent head and neck
cancer.
OBJECTIVES:
Primary
- Determine the biological activity and tolerability of fenretinide and lonafarnib in
patients with advanced or recurrent squamous cell carcinoma of the head and neck.
- Determine the toxicity profile of this regimen in these patients.
- Determine the maximum tolerated dose of this regimen in these patients.
Secondary
- Determine the dose-limiting toxicity of this regimen in these patients.
- Determine a recommended phase II dose of this regimen in these patients.
OUTLINE: This is a dose-escalation study followed by a randomized study.
- Dose-escalation portion: Patients receive oral fenretinide twice daily on days 1-7 and
oral lonafarnib twice daily on days 1*-21. Courses repeat every 21 days in the absence
of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of fenretinide and lonafarnib until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose-limiting toxicity.
- Randomized portion: After the dose-escalation portion of this study is completed,
additional patients (including patients who participate in the dose-escalation portion
of this study) are accrued and randomized to 1 of 4 dose levels. All patients receive
fenretinide and lonafarnib as in the dose-escalation portion of this study.
NOTE: *Lonafarnib is not administered on day 1 of course 1.
After completion of study treatment, patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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