Sirolimus in Treating Patients With Advanced Pancreatic Cancer

DISEASE CHARACTERISTICS:

Inclusion criteria

• Histologically proven adenocarcinoma of the pancreas
• Locally-advanced or advanced disease which has progressed after one prior gemcitabine-containing regimen
• Unidimensionally measurable disease (defined as at least one unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan) OR evaluable disease
• Tumor tissue available for IHC assessment OR willingness to undergo a safe biopsy of tumor tissue

Exclusion criteria

• Histologic or cytologic diagnosis that is not consistent with adenocarcinoma, including adenosquamous, islet cell, cystadenoma or cystadenocarcinoma, carcinoid, or small or large cell carcinoma or lymphoma
• Adenocarcinoma arising from a site other than the pancreas (e.g., distal common bile duct, ampulla of vater or periampullary duodenum)
• Known brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria

• ECOG performance status 0-1
• WBC > 3,500 cells/mm³
• ANC > 1,500 cells/mm³
• Hemoglobin > 9 g/dL
• Serum creatinine ≤ 2.0 mg/dL
• Bilirubin ≤ 2 mg/dL
• ALT, AST, and alkaline phosphatase ≤ 5 times upper limit of normal
• Triglycerides and total cholesterol 170 mm Hg, diastolic BP > 95 mm Hg)

PRIOR CONCURRENT THERAPY:

Exclusion criteria

• Any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy
• Any previous surgery, excluding minor procedures (e.g., dental work or skin biopsy) within 4 weeks of enrollment
• Participation in an investigational new drug trial within 1 month of starting trial
• Treatment with chemotherapy within 30 days of day 1 treatment
• At least 10 days since prior and no concurrent:
• Cyclosporine
• Diltiazem
• Ketoconazole
• Rifampin
• St. Johns wort
• Grapefruit juice
• Concurrent phenytoin, carbamazepine, barbiturates, or phenobarbital
• No other concurrent investigational or commercial agents