CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Pancreas
Eligibility Criteria
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (temsirolimus)
Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.