CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

  • Locally advanced or metastatic disease
• Radiographic evidence of disease
• No known brain metastases
• Performance status - ECOG 0-2
• More than 3 months
• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
• Creatinine ≤ 1.5 mg/dL
• Creatinine clearance ≥ 50 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Fasting serum cholesterol ≤ 350 mg/dL
• Fasting triglycerides ≤ 400 mg/dL
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No other concurrent uncontrolled illness
• No concurrent prophylactic hematopoietic colony-stimulating factors
• No prior chemotherapy for metastatic pancreatic cancer

• More than 2 months since prior adjuvant or neoadjuvant chemoradiotherapy for resected pancreatic cancer

  • Must have radiographic evidence of recurrent disease

• More than 2 months since prior chemoradiotherapy for locally advanced pancreatic cancer

  • Must have radiographic evidence of disease progression
• See Chemotherapy
• See Chemotherapy
• No other concurrent investigational or commercial agents or therapies for the malignancy
• No other concurrent anticancer therapy
• No concurrent combination antiretroviral therapy for HIV-positive patients