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

NCT ID: NCT00625352

Last Updated: 2008-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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Carcinoma, Non-Small-Cell Lung Aged Gemcitabine UFT

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Ulsan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ulsan University Hospital

Locations

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Ulsan University Hospital

Ulsan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Young Joo Min, M.D.

Role: CONTACT

Phone: 82-52-250-8832

Email: [email protected]

Facility Contacts

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Jin Sun Yoon

Role: primary

Other Identifiers

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UUH-ONC-0019

Identifier Type: -

Identifier Source: org_study_id