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Study of Developing an Optimal Gemcitabine Based Regimen to Treat Elderly Patients With Advanced Non-Small Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00625352
Recruitment Status : Unknown
Verified February 2008 by Ulsan University Hospital.
Recruitment status was:  Recruiting
First Posted : February 28, 2008
Last Update Posted : February 28, 2008
Sponsor:
Collaborator:
Jeil Pharmaceutical Co., Ltd.
Information provided by:
Ulsan University Hospital

Brief Summary:
Cares for elderly patients with advanced non-small cell lung cancer(NSCLC) become one of the common clinical practices oncologist are now facing. So, we need to seek adequate regimens for them. Gemcitabine is well known to be one of active third generation agents in terms of both efficacy and tolerability. Gemcitabine alone have been recommended as first line treatment for elderly NSCLC patients, especially in the aspect of tolerability. However, gemcitabine alone is suggested to be suboptimal to control their disease. Therefore, we plan to make an optimal regimen containing gemcitabine for the elderly patients.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Gemcitabine, UFT Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Phase II Trial of a Combination of Gemcitabine and UFT as First-Line Treatment in Elderly Patients With Advanced Non-Small Cell Carcinoma
Study Start Date : February 2008
Estimated Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Gemcitabine, UFT
    Gemcitabine 1,250mg/m2 IV on D1 and D8 of every 3 weeks combined with UFT 400mg daily PO for 14 days every 3 weeks. Gemcitabine will be administered to patients a maximum of 4 cycles, and then discontinued. UFT will be continued until progression.


Primary Outcome Measures :
  1. overall response rate [ Time Frame: every two cycles ]

Secondary Outcome Measures :
  1. toxicity, response duration, progression free survival, overall survival [ Time Frame: according to protocol ]


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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer Stage IIIB/IV
  • No prior chemotherapy
  • Existence of measurable disease. The measurable disease should not have been irradiated
  • Life expectancy of more than 3 months
  • Age ≥ 70 years
  • Performance status (ECOG):1 or 2
  • Adequate bone marrow function (Absolute neutrophil count >1500/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)
  • Adequate liver (Bilirubin<2 times upper limit of normal and SGOT/SGPT<3 times upper limit of normal) and renal function (creatinine<1.5mg/dl)
  • Informed consent

Exclusion Criteria:

  • Psychiatric illness or social situation that would preclude study compliance.
  • Other concurrent uncontrolled illness.
  • Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • Currently/recently taken warfarin, phenprocoumon or phenytoin
  • Hypersensitivity history to any drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625352


Contacts
Contact: Young Joo Min, M.D. 82-52-250-8832 yjmin@uuh.ulsan.kr

Locations
Korea, Republic of
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of, 682-714
Contact: Jin Sun Yoon    82-52-250-7010      
Sponsors and Collaborators
Ulsan University Hospital
Jeil Pharmaceutical Co., Ltd.

Responsible Party: Young Joo Min/Associate professor, Ulsan University Hospital
ClinicalTrials.gov Identifier: NCT00625352     History of Changes
Other Study ID Numbers: UUH-ONC-0019
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: February 28, 2008
Last Verified: February 2008

Keywords provided by Ulsan University Hospital:
Carcinoma, Non-Small-Cell Lung
Aged
Gemcitabine
UFT

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs