NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia
The purpose of this study is to determine the recommended dose of NC-6004 according to the dose-limiting toxicity (DLT) in combination with Gemcitabine, and to assess the efficacy, safety and tolerability.
Locally Advanced and Metastatic Pancreatic Cancer
Drug: Nanoplatin (NC-6004) and Gemcitabine
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of the Combination Therapy With NC-6004 and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer in Asian Countries|
- Incidence of DLT and Response rate [ Time Frame: DLT is evaluated for 3 weeks o the treatment, Response rate is evaluated at 7,13,19 and 25weeks of the treatment ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Nanoplatin (NC-6004) had to be administered once every 3 weeks, on Day 1, Day 22 and Day 43 etc.
Gemcitabine had to be administered to every patient 2 times on Day 1 and Day 8 every 3 weeks after the infusion of Nanoplatin (NC-6004).
|Drug: Nanoplatin (NC-6004) and Gemcitabine|
|National Cancer Centre Singapore|
|Singapore 169610, Singapore|
|Natinal Cheng Kung University Hospital|
|National Taiwan University Hospital|
|Taipei Veteran General Hospital|
|Chang Gung Memorial Hospital|
|Principal Investigator:||Wu-Chou Su, MD||National Cheng-Kung University Hospital|