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

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