Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck

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 gemcitabine in treating patients who have recurrent or metastatic adenoid cystic cancer of the head and neck.

Detailed description: OBJECTIVES:
  -  Assess the therapeutic activity of gemcitabine, in terms of objective response and duration of response, in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck.
  -  Determine the acute toxicity of this drug in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
  Patients are followed every 12 weeks until disease progression and then every 6 months thereafter.
  PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed metastatic or recurrent adenoid cystic carcinoma of the head and neck for which no curative options exist
  -  Symptomatic and/or progressive disease
  -  At least 1 unidimensionally measurable lesion
  -  At least 20 mm by conventional techniques OR
  -  At least 10 mm by spiral CT scan
  -  No bone metastases as only lesion
  -  Prior radiotherapy to only target lesion allowed if it has progressed or reappeared after radiotherapy
  -  No CNS metastases
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  WHO 0-2
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  WBC at least 3,500/mm^3
  -  Absolute neutrophil count at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  -  Hemoglobin at least 10 g/dL
  Hepatic:
  -  Bilirubin no greater than 1.25 times upper limit of normal (ULN) (2.5 times ULN if liver metastases present)
  -  AST or ALT less than 3 times ULN (5 times ULN if liver metastases present)
  Renal:
  -  Creatinine no greater than 1.7 mg/dL
  Other:
  -  No uncontrolled infection
  -  No concurrent serious systemic disorders that would preclude study
  -  No other prior or concurrent malignancy except:
  -  Adequately treated carcinoma in situ of the cervix
  -  Basal cell or squamous cell skin cancer
  -  Any malignancy that occurred more than 5 years ago with no symptoms or signs of recurrence (except malignant melanoma, hypernephroma, or breast carcinoma)
  -  No psychological, familial, sociological, or geographical condition that would preclude study compliance
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No concurrent immunotherapy
  Chemotherapy:
  -  No prior chemotherapy
  -  No other concurrent chemotherapy
  Endocrine therapy:
  -  No concurrent anti-estrogen therapy
  -  Concurrent steroid replacement or steroids as an antiemetic allowed
  Radiotherapy:
  -  See Disease Characteristics
  -  At least 3 months since prior radiotherapy except for palliative radiotherapy to bone lesions
  -  No concurrent radiotherapy
  Surgery:
  -  Not specified
  Other:
  -  At least 1 month since prior investigational agents
  -  No other concurrent experimental medications

Relevance to patient case: not relevant