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

Criterios de inclusión

• 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:
• 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