Literature DB >> 28314319

Multicenter Phase II Clinical Trial of Genexol-PM® with Gemcitabine in Advanced Biliary Tract Cancer.

Jin Young Kim1,2, Young Rok Do1, Hong Suk Song1, Yoon Young Cho3, Hun Mo Ryoo3, Sung Hwa Bae3, Jong Gwang Kim4, Yee Soo Chae4, Byung Woog Kang4, Jin Ho Baek5, Min Kyoung Kim6, Kyung Hee Lee6, Keonuk Park7.   

Abstract

This multicenter phase II clinical trial was designed to evaluate the efficacy and safety of weekly Genexol-PM® and gemcitabine combination chemotherapy in patients with unresectable or metastatic biliary tract cancer. PATIENTS AND METHODS: Patients received 100 mg/m2 Genexol-PM® and 1,000 mg/m2 gemcitabine intravenously on days 1 and 8 every 21 days.
RESULTS: Out of 39 patients, there were 10 partial responses (25.6%) and 18 with stable diseases (46.2%) were confirmed with median response duration 4.1 months. The median progression-free survival was 5.9±1.6 months and overall survival 11.9±1.4 months. The median number of cycles administered was 4.0 (range=1-10). Grade 3 or more neutropenia occurred in 12 patients (26.7%). The most common grade 3/4 non-hematological toxicities were febrile neutropenia (13.4%) and elevation of liver enzymes (6.7%).
CONCLUSION: Weekly Genexol-PM® combined with gemcitabine demonstrated sufficient antitumor activity to warrant further development when used as first-line chemotherapy for advanced biliary tract cancer. Copyright
© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Entities:  

Keywords:  Biliary tract cancer; chemotherapy; clinical trial; gemcitabine; paclitaxel; phase II; polymeric micelle

Mesh:

Substances:

Year:  2017        PMID: 28314319     DOI: 10.21873/anticanres.11471

Source DB:  PubMed          Journal:  Anticancer Res        ISSN: 0250-7005            Impact factor:   2.480


  8 in total

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Review 3.  Co-delivery systems: hope for clinical application?

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Journal:  Drug Deliv Transl Res       Date:  2021-08-16       Impact factor: 4.617

Review 4.  Polymeric micelles for the delivery of poorly soluble drugs: From nanoformulation to clinical approval.

Authors:  Duhyeong Hwang; Jacob D Ramsey; Alexander V Kabanov
Journal:  Adv Drug Deliv Rev       Date:  2020-09-24       Impact factor: 15.470

5.  Paclitaxel Restores Sensitivity to Chemotherapy in Preclinical Models of Multidrug-Resistant Intrahepatic Cholangiocarcinoma.

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Journal:  Front Oncol       Date:  2022-02-17       Impact factor: 6.244

6.  Docetaxel loaded mPEG-PLA nanoparticles for sarcoma therapy: preparation, characterization, pharmacokinetics, and anti-tumor efficacy.

Authors:  Jianhua Chen; Eerdunbagena Ning; Zhijun Wang; Ziqi Jing; Guijie Wei; Xue Wang; Pengkai Ma
Journal:  Drug Deliv       Date:  2021-12       Impact factor: 6.419

7.  An Assessment of Combination of the Camrelizumab With Chemotherapy in Metastatic Biliary Tract Cancers.

Authors:  Yi Yu; Shanshan Huang; Jun Chen; Feng Yu; Lin Zhang; Xiaojun Xiang; Jun Deng; Ziling Fang; Junhe Li; Jianping Xiong
Journal:  Cancer Control       Date:  2021 Jan-Dec       Impact factor: 3.302

8.  Unique anabolic action of stem cell gene therapy overexpressing PDGFB-DSS6 fusion protein in OVX osteoporosis mouse model.

Authors:  Wanqiu Chen; Samiksha Wasnik; Yawen Fu; Leslie Aranda; Charles H Rundle; Kin-Hing William Lau; David J Baylink; Xiaobing Zhang
Journal:  Bone Rep       Date:  2019-12-11
  8 in total

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