RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well CCI-779 works in treating patients with locally advanced or metastatic pancreatic cancer.

OBJECTIVES:

Primary

• Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779.

Secondary

• Determine time to progression, progression-free survival, overall survival, and tumor response rate in patients with measurable disease treated with this drug.
• Correlate biomarkers of response with clinical response in patients treated with this drug.
• Determine the safety and toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13 months.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

  • Locally advanced or metastatic disease
• Radiographic evidence of disease
• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)

Renal

• Creatinine ≤ 1.5 mg/dL OR
• Creatinine clearance ≥ 50 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent prophylactic hematopoietic colony-stimulating factors

Chemotherapy

• 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

Endocrine therapy

• Not specified

Radiotherapy

• See Chemotherapy

Surgery

• See Chemotherapy

Other

• 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