bms-247550 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 bms-247550 in treating patients who have advanced pancreatic cancer.

objectives: * determine the 6-month survival rate and time to treatment failure in patients with advanced pancreatic adenocarcinoma treated with bms-247550. * determine the frequency and severity of toxic effects of this drug in these patients. * determine the complete and partial response in those patients with measurable disease treated with this drug. * determine the pharmacokinetic profile of this drug in these patients. outline: this is a multicenter study. patients receive bms-247550 iv over 3 hours on day 1. courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. patients are followed every 6 months for 2 years and then annually until 3 years after registration. projected accrual: a total of 25-55 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed advanced pancreatic adenocarcinoma * distant metastases or * locoregional disease that has failed or is not amenable to locoregional therapy * no de novo locoregional disease * no known brain metastases patient characteristics: age: * adult performance status: * zubrod 0-1 life expectancy: * not specified hematopoietic: * absolute granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * sgot or sgpt no greater than 2.5 times uln * alkaline phosphatase less than 2.5 times uln renal: * creatinine no greater than 1.5 mg/dl cardiovascular: * no recent myocardial infarction, unstable angina, or life-threatening arrhythmia other: * not pregnant or nursing * fertile patients must use effective contraception * no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage i or ii cancer in remission * no prior severe hypersensitivity reaction to drugs containing cremophor el * no active or uncontrolled infection * no severe psychiatric disorders prior concurrent therapy: biologic therapy: * no prior neoadjuvant, adjuvant, or primary immunotherapy for advanced pancreatic cancer * no concurrent anticancer immunotherapy chemotherapy: * no prior neoadjuvant, adjuvant, or primary chemotherapy for advanced pancreatic cancer * no other concurrent anticancer chemotherapy endocrine therapy: * no prior neoadjuvant, adjuvant, or primary hormonal therapy for advanced pancreatic cancer * no concurrent anticancer hormonal therapy radiotherapy: * no prior neoadjuvant, adjuvant, or primary radiotherapy or chemoradiotherapy for advanced pancreatic cancer * prior palliative radiotherapy allowed if at least 1 lesion remains outside of radiation field or at least 1 lesion has progressed since radiotherapy * no concurrent anticancer radiotherapy except palliative radiotherapy to non-target metastatic sites surgery: * at least 2 weeks since prior surgery for pancreatic cancer and recovered other: * no other concurrent anticancer therapy * no concurrent herbal or unconventional therapy (e.g., st. john's wort)

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