A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or 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