Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of liposomal lurtotecan in treating patients who have metastatic or locally recurrent head and neck cancer.

Detailed description: OBJECTIVES:
  -  Determine the therapeutic activity of lurtotecan liposome in patients with metastatic or loco-regionally recurrent squamous cell carcinoma of the head and neck.
  -  Determine the objective response, duration of response, and time to progression in patients treated with this drug.
  -  Determine the toxicity profile of this drug in these patients.
  -  Determine the possible pharmacokinetic/pharmacodynamic relationship of this drug in these patients.
  OUTLINE: This is a multicenter study. Patients are stratified according to presence of a target lesion in a previously irradiated field (within vs outside).
  Patients receive lurtotecan liposome IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
  Patients are followed every 6 weeks.
  PROJECTED ACCRUAL: A total of 38-72 patients (19-36 per stratum) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed squamous cell carcinoma of the head and neck
  -  Metastatic or loco-regionally recurrent disease
  -  No undifferentiated or non-keratinizing carcinomas including lymphoepitheliomas
  -  No tumors of the nasal or paranasal cavities or of the nasopharynx
  -  Measurable disease
  -  No clinical symptomatic evidence of brain or leptomeningeal metastases
  -  Ineligible for loco-regional treatment after chemotherapy
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Neutrophil count at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  Bilirubin less than 1.5 times upper limit of normal (ULN)
  -  Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)
  Renal:
  -  Creatinine no greater than 1.5 times ULN
  -  No uncontrolled hypercalcemia
  Other:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception during and for 30 days after study
  -  No known hypersensitivity to systemic liposomal formulations or compounds chemically related to study drug
  -  No uncontrolled systemic disease or infection
  -  No psychological, familial, sociological, or geographical condition that would preclude study
  -  No other prior or concurrent malignancy except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No concurrent anticancer biological therapy or immune response modifiers
  -  No concurrent prophylactic hematopoietic growth factors
  Chemotherapy:
  -  See Disease Characteristics
  -  No prior chemotherapy for recurrent disease
  -  No prior therapy with camptothecin analogues
  -  At least 8 weeks since prior neoadjuvant or adjuvant chemotherapy
  -  No other concurrent anticancer cytotoxic therapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  At least 8 weeks since prior radiotherapy and recovered
  Surgery:
  -  Not specified
  Other:
  -  At least 30 days since prior experimental drug

Relevance to patient case: not relevant