perifosine in treating patients with advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of perifosine in treating patients who have locally advanced or metastatic pancreatic cancer.

objectives: * determine the efficacy of perifosine, in terms of 6-month survival, in patients with advanced adenocarcinoma of the pancreas. * determine the safety and tolerability of this drug in these patients. * determine median survival time and the 1-year survival rate of patients treated with this drug. * determine the objective response rate (partial and complete), response duration, and time to progression in patients treated with this drug. * determine the toxicity of this drug in these patients. outline: patients receive oral perifosine daily for 3 weeks. 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 17-37 patients will be accrued for this study within 15 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed adenocarcinoma of the pancreas not amenable to curative local therapy * metastatic or locally advanced * no known brain metastases * no ascites that required therapeutic paracentesis on at least 2 occasions within the past 6 weeks patient characteristics: age * 18 and over performance status * ecog 0-2 or * karnofsky 60-100% life expectancy * not specified hematopoietic * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic * bilirubin no greater than 2 times upper limit of normal (uln) * ast/alt no greater than 2.5 times uln (5 times uln with liver metastases) renal * creatinine normal or * creatinine clearance at least 60 ml/min cardiovascular * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia gastrointestinal * no gastrointestinal (gi) tract disease resulting in the inability to take oral medication or a requirement for iv alimentation * no uncontrolled inflammatory bowel disease * no active peptic ulcer disease other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine * no other active malignant disease that could interfere with interpretation of study results * no ongoing active infection * no other uncontrolled concurrent illness * no psychiatric illness or social situation that would preclude study compliance prior concurrent therapy: biologic therapy * not specified chemotherapy * no more than 1 prior chemotherapy regimen for metastatic or locally advanced disease * prior chemotherapy, given as a radiosensitizer, allowed in addition to single-line therapy * at least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered endocrine therapy * not specified radiotherapy * at least 3 weeks since prior radiotherapy likely to have myelotoxic effects (more than 3,000 cgy to fields including substantial marrow) and recovered surgery * no prior gi surgery affecting absorption other * no concurrent antiretroviral therapy for hiv-positive patients * no other concurrent investigational agents * no other concurrent anticancer agents or therapies

Keywords: recurrent pancreatic cancer stage ii pancreatic cancer adenocarcinoma of the pancreas stage iii pancreatic cancer stage iv pancreatic cancer