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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Ulsan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Jeil Pharmaceutical Co., Ltd.
Information provided by:
Ulsan University Hospital
ClinicalTrials.gov Identifier:
NCT00625352
First received: February 19, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Gemcitabine, UFT
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: Prospective Phase II Trial of a Combination of Gemcitabine and UFT as First-Line Treatment in Elderly Patients With Advanced Non-Small Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Ulsan University Hospital:

Primary Outcome Measures:
  • overall response rate [ Time Frame: every two cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity, response duration, progression free survival, overall survival [ Time Frame: according to protocol ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: February 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Young Joo Min/Associate professor, Ulsan University Hospital
ClinicalTrials.gov Identifier: NCT00625352     History of Changes
Other Study ID Numbers: UUH-ONC-0019
Study First Received: February 19, 2008
Last Updated: February 19, 2008
Health Authority: South Korea: Institutional Review Board

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
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 July 10, 2014