AZD0530 and Gemcitabine in Locally Advanced/Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed pancreatic adenocarcinoma
• * Unresectable disease
• * Locally advanced or metastatic disease
• Clinically or radiologically documented disease
• * Measurable or evaluable disease (phase I)
• * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan (phase II)
• * Measurable lesion must be outside of previously irradiated field if it is the sole site of disease unless there is documented disease progression
• No known brain metastases
• PATIENT CHARACTERISTICS:
• Performance status
• ECOG 0-2
• Life expectancy
• More than 12 weeks
• Hematopoietic
• Platelet count ≥ 100,000/mm\^3
• Absolute granulocyte count ≥ 1,500/mm\^3
• Hepatic
• Bilirubin normal
• AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if clearly attributable to liver metastasis)
• Renal
• Creatinine normal
• Cardiovascular
• No active cardiomyopathy
• No congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No uncontrolled hypertension
• No myocardial infarction within the past 12 months
• Pulmonary
• No pulmonary disease requiring oxygen supplementation
• Gastrointestinal
• Must not require IV hyperalimentation
• No uncontrolled inflammatory gastrointestinal (GI) disease (e.g., Crohn's disease or ulcerative colitis)
• No active peptic ulcer disease
• No postsurgical malabsorption characterized by uncontrolled diarrhea that results in weight loss and vitamin deficiency
• No other GI tract disease resulting in an inability to take oral medications
• Must be able to take oral medication without crushing, dissolving, or chewing tablets
• Pancreatic enzyme supplementation allowed provided the above conditions are met
• Immunologic
• No immune deficiency
• No active, uncontrolled, or serious infection
• No know hypersensitivity to study drugs or their components
• No known HIV positivity
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of psychiatric illness (e.g., uncontrolled psychotic disorders) or neurologic disorder that would preclude study compliance
• No other serious medical condition or illness that would preclude study participation
• No other malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix or bladder
• PRIOR CONCURRENT THERAPY:
• Chemotherapy
• No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or gemcitabine given concurrently with radiotherapy as a radiosensitizer
• * At least 4 weeks since prior fluorouracil or gemcitabine
• Endocrine therapy
• Concurrent systemic hormonal therapy for symptom control (e.g., appetite stimulation, pain, or nausea) allowed
• Radiotherapy
• See Disease Characteristics
• See Chemotherapy
• At least 4 weeks since prior radiotherapy for local disease and recovered
• Surgery
• At least 3 weeks since prior major surgery
• Other
• At least 2 weeks since prior anticancer therapy or investigational agents
• The following drugs must not be used for 1-2 weeks before, during, and for 1-2 weeks after completion of study treatment:
• * Ketoconazole
• * Itraconazole
• * Ritonavir
• * Mibefradil
• * Clarithromycin
• * Saquinavir mesylate
• * Indinavir sulfate
• * Erythromycin
• * Nefazodone hydrochloride
• * Fluconazole
• * Diltiazem hydrochloride
• * Alfentanil hydrochloride
• * Carbamazepine
• * Cyclosporine
• * Tacrolimus
• * Lovastatin
• * Simvastatin
• * Any other drug known to be a potent inhibitor of cytochrome 3A4
• No other concurrent anticancer therapy or investigational agents