Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: SU5416 in Treating Patients With Advanced or Recurrent Cancer of the Head and Neck

Summary: RATIONALE: SU5416 may stop the growth of cancer cells by stopping blood flow to the tumor.
  PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced or recurrent cancer of the head and neck.

Detailed description: OBJECTIVES:
  -  Determine the effect of SU5416 on survival and tumor response in patients with advanced or recurrent squamous cell carcinoma of the head and neck.
  -  Determine the safety and toxicity of SU5416 in these patients.
  OUTLINE: Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
  Patients are followed for 1 year.
  PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 1.4 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven epidermoid/squamous cell carcinoma of the oral cavity, lip, hypopharynx, oropharynx, nasopharynx, sinonasal tract, or larynx; undifferentiated carcinoma of the nasopharynx (WHO type III); sinonasal undifferentiated carcinoma; or squamous cell carcinoma of unknown primary or the skin with initial presentation in the head and neck region
  -  Advanced or recurrent disease that is incurable with surgery or radiotherapy
  -  No more than 2 prior cytotoxic chemotherapy regimens for recurrent, persistent, or metastatic disease
  -  Prior exposure to chemopreventive agents (e.g., tretinoin or other vitamin analogues) is not considered to be a prior cytotoxic chemotherapy exposure
  -  At least 1 measurable indicator lesion
  -  Bone metastases, elevated enzyme levels, or lesions on radionuclide scans are not acceptable as the sole parameters of measurable disease
  -  No history of brain metastases
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  Karnofsky 60-100%
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  WBC greater than 3,000/mm3
  -  Hemoglobin greater than 8 g/dL
  -  Platelet count greater than 100,000/mm3
  -  No history of coagulation disorder
  Hepatic:
  -  Bilirubin normal
  -  SGOT less than 2.5 times upper limit of normal
  -  PT no greater than 14 seconds
  -  aPTT no greater than 40 seconds
  Renal:
  -  Creatinine less than 1.5 mg/dL OR
  -  Creatinine clearance at least 60 mL/min
  Cardiovascular:
  -  No uncompensated coronary artery disease
  -  No myocardial infarction or severe/unstable angina within the past 6 months
  -  No severe peripheral vascular disease associated with diabetes mellitus
  -  No deep venous or arterial thrombosis within the past 3 months
  -  No unstable cardiac rhythm
  -  No cerebrovascular accident within the past 6 months
  Pulmonary:
  -  No pulmonary embolism within the past 3 months
  Other:
  -  No history of allergic reaction to paclitaxel
  -  No other active malignancy except:
  -  Basal cell or squamous cell skin cancer
  -  Carcinoma in situ of the cervix
  -  Synchronous epidermoid/squamous cell carcinoma of the head and neck (oral cavity, lip, hypopharynx, oropharynx, nasopharynx, sinonasal tract, or larynx)
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No active bacterial infection requiring antibiotics
  -  No other concurrent medical condition that would increase risk
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  See Disease Characteristics
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  See Disease Characteristics
  -  More than 4 weeks since prior radiotherapy
  Surgery:
  -  See Disease Characteristics

Relevance to patient case: not relevant