Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed adenocarcinoma of the pancreas
• •Locally advanced or metastatic disease that is considered unresectable
• •No known CNS metastases
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •ECOG 0-2
• •Life expectancy:
• •Not specified
• •Hematopoietic:
• •Absolute granulocyte count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic:
• •Bilirubin less than 2 times upper limit of normal (ULN)
• •AST and/or ALT less than 2 times ULN (5 times ULN if liver metastases present)
• •Renal:
• •Creatinine less than 1.5 times ULN
• •Cardiovascular:
• •No uncontrolled high blood pressure
• •No unstable angina
• •No congestive heart failure
• •No myocardial infarction within the past year
• •No cardiac ventricular arrhythmias requiring medication
• •Gastrointestinal:
• •No gastrointestinal (GI) tract disease resulting in an inability to take oral medication such as uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
• •No post-surgical malabsorption characterized by:
• •* Uncontrolled diarrhea that results in weight loss and vitamin deficiency OR
• •* Requires IV hyperalimentation
• •* Pancreatic enzyme supplementation allowed provided that the above criteria are not met
• •Ophthalmic:
• •No ocular inflammation or infection unless fully treated prior to study
• •No significant ophthalmologic abnormalities, including the following:
• •* Severe dry eye syndrome
• •* Sjogren's syndrome
• •* Keratoconjunctivitis sicca
• •* Severe exposure keratopathy
• •* Disorders that would increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
• •Other:
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •HIV negative
• •No serious active infection
• •No other serious underlying medical, psychological, or geographical condition that would preclude study participation
• •No prior allergic reaction to compounds with similar chemical or biologic composition to erlotinib
• •No other prior malignancy within the past 5 years except cancer in situ or basal cell or squamous cell skin cancer
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No concurrent biologic therapy or immunotherapy
• •Chemotherapy:
• •No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or gemcitabine administered concurrently with radiotherapy as a radiosensitizer
• •No other concurrent cytotoxic chemotherapy
• •Endocrine therapy:
• •Not specified
• •Radiotherapy:
• •See Chemotherapy
• •At least 4 weeks since prior radiotherapy and recovered
• •Prior radiotherapy for local disease allowed if evidence of disease progression has occurred
• •No concurrent radiotherapy
• •Surgery:
• •See Disease Characteristics
• •At least 2 weeks since prior major surgery
• •No concurrent ophthalmic surgery
• •Other:
• •No prior epidermal growth factor receptor inhibitors
• •At least 2 weeks since prior investigational drug
• •No other concurrent investigational drugs during and for at least 30 days after study
• •No other concurrent anti-cancer therapy