A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers

Study Name
  A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers
ClinicalTrials.gov Identifier (if applicable)
  NCT02392637
Study Center
Institution Name
  MD Anderson Cancer Center
Institution Address
  1515 Holcombe Blvd, Unit 426
City
  Houston
State
  Texas
Zip Code
  77030
Phone
  (713) 792-2828
List additional Institutions (include address, phone number, and website)
  Mayo Clinic Scottsdale
Study Contacts
Principal Investigator
  Rachna Shroff, MD
P.I. Phone
  (713) 792-2828
P.I. Email
  rshroff@mdanderson.org
List additional Principal Investigators (include phone number and email)
  Mitesh Borad, MD
Study Coordinator
  Michiko Iwasaki
Study Coordinator Phone
  (713) 792-2828
Study Coordinator Email
  miwasaki@mdanderson.org
OVERVIEW – in layman’s terms (150 words max)
  The purpose of this study is to test the efficacy of adding nab-paclitaxel (Abraxane) to gemcitabine and cisplatin in patients with advanced, newly diagnosed biliary cancers. Patients will be evaluated for progression-free survival, overall survival and response rate.
Enrollment
  50
Study Start Date
  04/20/2015
Estimated Completion Date
  08/31/2016
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
 
  • To test the progression-free survival of gemcitabine, cisplatin, and nab-paclitaxel in patients with advanced biliary cancers
Inclusion Criteria – Patients Must:
 
  • Have pathologically confirmed cholangiocarcinoma or gallbladder cancer
  • Have not received any prior therapy
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
 
  • CT scans
POTENTIAL SIDE-EFFECTS – in layman’s terms
 
  • Decreased blood counts, fatigue, nausea, vomiting, neuropathy

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