Phase II Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients with Advanced Pancreatic Cancer
| Autor: | Elin Rowen, Min-Young Lee, Nikolai A. Podoltsev, Jin-Won Kwon, Muhammad Wasif Saif, Robert O. Kerr, Jaewon Yu, Jose A. Figueroa, Mark S. Rubin |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Paclitaxel medicine.medical_treatment Phases of clinical research Gastroenterology Disease-Free Survival Drug Administration Schedule Internal medicine Pancreatic cancer medicine Clinical endpoint Humans Progression-free survival Paclitaxel-Loaded Polymeric Micelle Neoplasm Metastasis Micelles Aged Aged 80 and over Chemotherapy business.industry General Medicine Middle Aged medicine.disease Antineoplastic Agents Phytogenic Surgery Pancreatic Neoplasms Clinical trial Oncology Tumor progression Female business |
| Zdroj: | Cancer Investigation. 28:186-194 |
| ISSN: | 1532-4192 0735-7907 |
| Popis: | To determine in patients, with locally advanced or metastatic pancreatic cancer (APC), efficacy and safety of treatment with intravenous paclitaxel loaded polymeric micelle (GPM).This was a multicenter, open-label Phase II study. Patients with APC, ECOG performance statusor = 2, no prior chemotherapy and adequate organ function were treated with 3-hour GPM infusions every 3 weeks. Initial patients were treated with 435 mg/m(2) (n = 11). The dose was reduced for subsequent patients to 350 or 300 mg/m(2) (n = 45). Primary endpoint was time to tumor progression (TTP).56 patients were enrolled. Median TTP for patients treated with 300 or 350 mg/m(2) doses was 3.2 months (95% CI, 2.6-4.2). Median progression free survival (PFS) was 2.8 months (95% CI, 1.4-4.0). Median overall survival (OS) was 6.5 months (95% CI, 5.1-7.9). Among patients treated with above doses of GPM, there was 1 complete remission (CR) and 2 partial remissions (PR) with an overall response rate (ORR) of 6.7%. Disease control rate (CR + PR + stable disease) was 60.0%. Most common grade 3 toxicities were: neutropenia (40.0%), fatigue (17.8%), infection, dehydration, neuropathy (each 13.3%), and abdominal pain (11.1%).Treatment of APC with GPM at a dose of 300 mg/m(2) q 3 weeks was well tolerated and common toxicities were qualitatively similar to Cremophor-based paclitaxel. GPM monotherapy resulted in OS and other efficacy parameters preferable to that seen historically with gemcitabine. Future studies of GPM in combination with other agents for treatment of APC are warranted. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|