Phase II Trial of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer

Date de début de l'étude : 1 décembre 2003

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