NC-6004(Nanoplatin) And Gemcitabine To Treat Pancreatic Cancer In Asia

Study Overview

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.

N/A

Locally Advanced and Metastatic Pancreatic Cancer

DRUG: Nanoplatin (NC-6004) and Gemcitabine

NC-6004-002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-05-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-01-08
First Submitted that Met QC Criteria 2009-05-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-01-09
First Posted (ESTIMATED) 2009-06-01	Results First Posted N/A	Last Verified 2014-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Nanoplatin 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Nanoplatin

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

Primary Outcome Measures	Measure Description	Time Frame
Incidence of DLT and Response rate		DLT is evaluated for 3 weeks o the treatment, Response rate is evaluated at 7,13,19 and 25weeks of the treatment

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival		1.5 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

Patients with chemo-naive, advanced pancreatic cancer
Nonresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer

Pulmonary fibrosis or interstitial pneumonia
Marked pleural effusion or ascites above Grade 2
Severe drug hypersensitivity
Metastasis to the central nervous system and brain

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Orient Europharma Co., Ltd.

Investigators

PRINCIPAL_INVESTIGATOR: Wu-Chou Su, MD, National Cheng-Kung University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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Resources

PatientS

Caregivers

Clinical Trial Record