arsenic trioxide in treating patients with pancreatic cancer that has not responded to gemcitabine

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 arsenic trioxide in treating patients who have locally advanced or metastatic pancreatic cancer that has not responded to gemcitabine.

objectives: * determine the objective response rate to arsenic trioxide in patients with pancreatic cancer who have progressed after first-line treatment with a gemcitabine-containing regimen when treated with arsenic trioxide. * determine the toxicity of this drug in these patients. * determine the duration of response, median and overall survival, and time to progression in patients treated with this drug. outline: this is a multicenter study. patients receive arsenic trioxide iv over 1 hour on days 1-5. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. patients are followed for survival. projected accrual: a total of 12-37 patients will be accrued for this study within 9-12 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed adenocarcinoma of the pancreas * locally advanced or metastatic disease * unidimensionally measurable disease * at least 1 lesion that is at least 20 mm with conventional techniques or at least 10 mm with spiral ct scan * must have progressed after chemotherapy with a gemcitabine-containing regimen * no known brain metastases patient characteristics: age * over 18 performance status * ecog 0-1 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 1.5 mg/dl * ast/alt no greater than 5 times upper limit of normal renal * creatinine no greater than 1.5 mg/dl or * creatinine clearance at least 60 ml/min cardiovascular * qtc less than 500 msec at baseline by ekg * no new york heart association class iii or iv heart failure * 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 * no prior allergic reactions attributed to compounds of similar chemical or biological composition to arsenic trioxide * no other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * no ongoing or active infection * no psychiatric illness or social situation that would preclude study compliance * no other uncontrolled illness prior concurrent therapy: biologic therapy * no concurrent immunotherapy * no concurrent colony-stimulating factors during the first course of the study chemotherapy * see disease characteristics * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * no prior arsenic trioxide * no other concurrent chemotherapy * no more than 1 prior chemotherapy regimen for metastatic disease endocrine therapy * no concurrent hormonal therapy radiotherapy * at least 4 weeks since prior radiotherapy and recovered * no concurrent therapeutic radiotherapy surgery * at least 4 weeks since major surgery other * no other concurrent investigational or commercial anticancer agents or therapies * no other concurrent investigational agents * no concurrent antiretroviral therapy in hiv-positive patients * no concurrent medications for other comorbid conditions that are known to prolong the qt interval

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