A Phase II Study of Gemcitabine in Combination With Doxorubicin for Patients With Head and Neck Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

- Histologically or cytologically confirmed head and neck cancer

- Recurrent or progressive disease

- Must have measurable disease, defined as at least one lesion that can be accurately
measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by
conventional techniques or as ≥ 10 mm by spiral CT scan

- Must have received prior platinum-based chemotherapy regimen (cisplatin or
carboplatin) with or without radiotherapy, unless the patient was deemed unsuitable
for platinum-based therapy due to renal dysfunction or other clinical
contraindication

Exclusion criteria:

- Known brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

- ECOG performance status (PS) ≤ 2 OR Karnofsky PS ≥ 60%

- Absolute neutrophil count ≥ 1,500/μL

- Platelets ≥ 100,000/µL

- Total bilirubin ≤ 1.5 mg/dL

- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal

- Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 30 mL/min

- Females of reproductive potential must not plan on conceiving children during study
treatment period and must agree to use adequate contraception (hormonal or barrier
method of birth control or abstinence) prior to study entry and for the duration of
the study

Exclusion criteria:

- Not pregnant or breastfeeding

- History of allergic reaction attributed to compounds of similar chemical or
biological composition to gemcitabine hydrochloride or doxorubicin hydrochloride

- Lower than normal cardiac ejection fraction

- Patients must have an echocardiogram or MUGA scan prior to the use of study
drugs

- Uncontrolled intercurrent illness that would limit compliance with study requirements
including, but not limited to, any of the following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation

- Clinical AIDS or known positive HIV serology

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

- Recovered from prior therapy

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)

- At least 30 days since prior experimental agents

- At least 4 weeks since prior radiotherapy for palliation or for the primary tumor

Exclusion criteria:

- Prior gemcitabine hydrochloride or doxorubicin hydrochloride

- Concurrent hormones or other chemotherapeutic agents, except for steroids given for
adrenal failure, hormones given for non-disease-related conditions (e.g., insulin for
diabetes), or intermittent use of dexamethasone as an antiemetic

- Concurrent palliative radiotherapy

- Other concurrent investigational or commercial agents or therapies