safety and efficacy study of different doses of 90y-hpam4 combined with gemcitabine in pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is a study to test whether different doses of 90y-hpam4 are safe to give in combination with gemcitabine in patients with previously untreated pancreatic cancer.

patients receive a 4-week treatment cycle with once-weekly 30-minute gemcitabine infusions beginning one week prior to the first 90y-hpam4dose and continuing during the 3 consecutive weeks over which once weekly 90y-hpam4 doses are given. depending on toxicity, patient cohorts will receive one of several possible 90y and gemcitabine dose combinations. post-treatment evaluations conducted until instituting another 90yhpam4 treatment cycle, maintenance gemcitabine or for a maximum period of 12 weeks.

Eligibility criteria:
inclusion criteria: * male or female patients, \>18 years of age, who are able to understand and give written informed consent. * histologically or cytologically confirmed pancreatic adenocarcinoma. * stage iii (locally advanced, unresectable) or stage iv (metastatic) disease, including patients who underwent surgery but had incomplete resections. * treatment naïve (no prior chemotherapy, radiotherapy or investigational agents for pancreatic cancer) * karnofsky performance status \> 70 % (appendix a). * expected survival \> 3 months. * at least 4 weeks beyond major surgery and recovered from all acute toxicities * at least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis * adequate hematology without ongoing transfusional support (hemoglobin \> 11 g/dl, anc \> 2,000 per mm3, platelets \> 150,000 per mm3) * adequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 x iuln, ast and alt ≤ 2.0 x iuln) * otherwise, all toxicity at study entry \<grade 1 by nci ctc v3.0. exclusion criteria: * women who are pregnant or lactating. * women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period. * known metastatic disease to the central nervous system. * presence of bulky disease (defined as any single mass \>10 cm in its greatest dimension) * patients with \>grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction. * prior radiation dose \>3,000 cgy to the liver, \>2,000 cgy to lungs and kidneys or prior external beam irradiation to a field that includes more than 30% of the red marrow. * patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 5-year disease free interval. * patients known to be hiv positive, hepatitis b positive, or hepatitis c positive. * known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months or cardiac arrhythmia requiring anti-arrhythmia therapy. * known history of active copd, or other moderate-to-severe respiratory illness present within 6 months. * known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids). * infection requiring intravenous antibiotic use within 1 week. * other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Keywords: pancreatic cancer hpam4 muc1 antibody cancer of the pancreas