NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia

This study has been completed.
Sponsor:
Collaborator:
Orient Europharma Co., Ltd.
Information provided by (Responsible Party):
Nanocarrier Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00910741
First received: May 29, 2009
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Locally Advanced and Metastatic Pancreatic Cancer
Drug: Nanoplatin (NC-6004) and Gemcitabine
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Nanocarrier Co., Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: May 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910741

Locations
Singapore
National Cancer Centre Singapore
Singapore 169610, Singapore
Taiwan
Natinal Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veteran General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Sponsors and Collaborators
Nanocarrier Co., Ltd.
Orient Europharma Co., Ltd.
Investigators
Principal Investigator: Wu-Chou Su, MD National Cheng-Kung University Hospital
  More Information

Publications:
Responsible Party: Nanocarrier Co., Ltd.
ClinicalTrials.gov Identifier: NCT00910741     History of Changes
Other Study ID Numbers: NC-6004-002
Study First Received: May 29, 2009
Last Updated: January 8, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Nanocarrier Co., Ltd.:
pancreatic cancer
Gemcitabine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 17, 2014