Back to resultsNC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia
Primary Purpose
Locally Advanced and Metastatic Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Nanoplatin (NC-6004) and Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced and Metastatic Pancreatic Cancer focused on measuring pancreatic cancer, Gemcitabine
Eligibility Criteria
Inclusion Criteria:
- Patients with chemo-naive, advanced pancreatic cancer
- Nonresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer
Exclusion Criteria:
- Pulmonary fibrosis or interstitial pneumonia
- Marked pleural effusion or ascites above Grade 2
- Severe drug hypersensitivity
- Metastasis to the central nervous system and brain
Sites / Locations
- National Cancer Centre Singapore
- Natinal Cheng Kung University Hospital
- National Taiwan University Hospital
- Taipei Veteran General Hospital
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nanoplatin
Arm Description
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).
Outcomes
Primary Outcome Measures
Incidence of DLT and Response rate
Secondary Outcome Measures
Overall survival
Full Information
NCT ID
NCT00910741
First Posted
May 29, 2009
Last Updated
January 8, 2014
Sponsor
NanoCarrier Co., Ltd.
Collaborators
Orient Europharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00910741
Brief Title
NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NanoCarrier Co., Ltd.
Collaborators
Orient Europharma Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced and Metastatic Pancreatic Cancer
Keywords
pancreatic cancer, Gemcitabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nanoplatin
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Nanoplatin (NC-6004) and Gemcitabine
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
1.5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with chemo-naive, advanced pancreatic cancer
Nonresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer
Exclusion Criteria:
Pulmonary fibrosis or interstitial pneumonia
Marked pleural effusion or ascites above Grade 2
Severe drug hypersensitivity
Metastasis to the central nervous system and brain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu-Chou Su, MD
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Centre Singapore
City
Singapore 169610
Country
Singapore
Facility Name
Natinal Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veteran General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
16222314
Citation
Uchino H, Matsumura Y, Negishi T, Koizumi F, Hayashi T, Honda T, Nishiyama N, Kataoka K, Naito S, Kakizoe T. Cisplatin-incorporating polymeric micelles (NC-6004) can reduce nephrotoxicity and neurotoxicity of cisplatin in rats. Br J Cancer. 2005 Sep 19;93(6):678-87. doi: 10.1038/sj.bjc.6602772.
Results Reference
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NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia
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