A Phase II Study of AZD0530 for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Inclusion Criteria
DISEASE CHARACTERISTICS:
Inclusion criteria:
- Histologically or cytologically confirmed squamous cell carcinoma of the head and
neck
- Persistent, recurrent, or metastatic disease that is not amenable to
curative-intent therapy with surgery or radiation
- Measurable disease, defined as at least one lesion that can be accurately measured in
at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional
techniques or ≥ 10 mm with spiral CT scan
Exclusion criteria:
- Known brain metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Karnofsky performance status ≥ 60%
- WBC ≥ 3,000/mcL
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Hemoglobin > 9 g/dL
- Total bilirubin within upper institutional limits of normal (ULN)
- AST/ALT ≤ 2.5 x ULN
- Creatinine within ULN OR creatinine clearance ≥ 60 mL/min
- Patients must agree to use adequate birth control for the duration of study
participation and for at least 8 weeks after discontinuation of study drug
Exclusion criteria:
- History of allergic reactions attributed to compounds of similar chemical or
biological composition to AZD0530
- Urine protein:creatinine ratio ≥ 1.0 OR 24-hour urine protein ≥ 1,000 mg
- QTc prolongation ≥ 480 msecs
- Intercurrent symptomatic congestive heart failure, unstable angina pectoris, or
cardiac arrhythmia
- History of myocardial infarction within the past year
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements
- Pregnant or breastfeeding women
- HIV-positive patients on combination antiretroviral therapy
- Pulmonary fibrosis ≥ grade 2, pleural effusion (non-malignant) ≥ grade 2, or
pneumonitis/pulmonary infiltrates ≥ grade 2
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- May have received 1 prior cytotoxic chemotherapy regimen for recurrent or metastatic
disease
Exclusion criteria:
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study
- Patients who have not recovered from adverse events due to agents administered more
than 4 weeks earlier
- Use of specifically prohibited CYP3A4-active agents or substances
- Prohibited drugs should be discontinued 7 days prior to the administration of
the first dose of AZD0530 and for 7 days following discontinuation of AZD0530
- Patients receiving any other investigational agents