Fenretinide and Lonafarnib in Treating Patients With Advanced or Recurrent Head and Neck Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck

  • Advanced or recurrent disease
• Considered incurable by standard measures
• Tumor tissue accessible for biopsy

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• stern Cooperative Oncology Group (ECOG) 0-1

Life expectancy

• Not specified

Hematopoietic

• White Blood Count (WBC) ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL

Hepatic

• Bilirubin ≤ 2.0 mg/dL
• Albumin ≥ 2.5 g/dL
• Aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT) ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal OR
• Alkaline phosphatase ≤ 4 times Upper Limit of Normal (ULN) AND Aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT) normal

Renal

• Creatinine < 2 mg/dL

Cardiovascular

• No history of uncontrolled heart disease
• No arrhythmia
• No angina
• No congestive heart failure
• No other heart condition that cannot be controlled with regular ongoing medication

Gastrointestinal

• Able to swallow oral medication
• No requirement for total parenteral nutrition with lipids

Neurological

• No significant neuropathy
• No neurotoxicity ≥ grade 3 from prior anticancer treatment

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-method contraception during and for at least 1 month after study participation
• No signs or symptoms of acute infection requiring systemic therapy
• No confusion, disorientation, or major psychiatric illness that would preclude giving informed consent
• No serious infection requiring immediate therapy
• No other illness requiring immediate therapy
• No pre-existing retinopathy
• No other medical or social factor that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Chemotherapy

Chemotherapy

• No more than 2 prior chemotherapeutic regimens for recurrent or metastatic disease

  • Prior biologic therapy not considered a chemotherapeutic regimen

Endocrine therapy

• More than 2 days since prior and no concurrent high-dose chronic steroids
• More than 2 days since prior and no concurrent ethinylestradiol
• No concurrent anticancer hormonal therapy

Radiotherapy

• More than 6 months since prior radiotherapy
• No concurrent radiotherapy

Surgery

• No prior surgery that may affect the ability to swallow study drugs

Other

• More than 2 days since prior and no concurrent cytochrome P450 3A4 (CYP3A4) inducers or inhibitors, including any of the following:

  • Gestodene
  • Itraconazole
  • Ketoconazole
  • Cimetidine
  • Erythromycin
  • Carbamazepine
  • Phenobarbital
  • Phenytoin
  • Rifampin
  • Sulfinpyrazone
  • Grapefruit juice
• More than 30 days since prior high-dose vitamin A
• No concurrent high-dose synthetic or natural vitamin A derivatives (> 10,000 IU/day)
• No concurrent antioxidants (e.g., vitamin E or vitamin C)
• No other concurrent investigational agents
• No other concurrent antineoplastic agents