Phase I

Summary:

Paclitaxel is widespreadly used in chemotherapy diets due to its antitumor activity, which causes severe and even lethal toxicity and also severe allergic reactions. Abraxan is an albumin-bound formulation derived from Paclitaxel which lacks paclitaxel-related toxicities. Recently, a formulation similar to Abraxan, nemedPaclinab, have been produced which in vitro studies indicate its acceptable function. Therefore, this study is aimed to evaluate Paclinab efficiency and its comparison with Abraxan in pancreatic cancer patients. This study will perform in two groups, on twenty pancreatic cancer patients with a randomized crossover diet containing paclitaxel for comparison of Paclinab and Abraxan formulations. In the first cycle, one group will receive a dosage of Paclinab and another one will receive a dosage of Abraxan (125 mg/m2 of body surface area during 30 min infusion), under medical care. In next cycle (3-week cycles) the group which received Abraxan, will receive Paclinab and the other group will receive the drug with the same dosage, vice versa. Assessment of blood samples will be done for comparison of pharmacokinetic parameters of both formulations at different times, before the infusion initiation, 15 min after the infusion initiation, 2-5 min before the infusion termination, and also 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h and 48 h after infusion termination. Measurement of Paclitaxel is performed in all samples using a high fluid pressure chromatography analysis method.