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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Gemcitabine, UFT

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Carcinoma, Non-Small-Cell Lung, Aged, Gemcitabine, UFT

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ulsan University HospitalRecruiting

Outcomes

Primary Outcome Measures

overall response rate

Secondary Outcome Measures

toxicity, response duration, progression free survival, overall survival

Full Information

NCT ID

NCT00625352

First Posted

February 19, 2008

Last Updated

February 19, 2008

Sponsor

Ulsan University Hospital

Collaborators

Jeil Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00625352

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Unknown status

Study Start Date

February 2008 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Ulsan University Hospital

Collaborators

Jeil Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell Lung, Aged, Gemcitabine, UFT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Gemcitabine, UFT

Intervention Description

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 Measure Information:

Title

overall response rate

Time Frame

every two cycles

Secondary Outcome Measure Information:

Title

toxicity, response duration, progression free survival, overall survival

Time Frame

according to protocol

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Young Joo Min, M.D.

Phone

82-52-250-8832

yjmin@uuh.ulsan.kr

Facility Information:

Facility Name

Ulsan University Hospital

City

Ulsan

ZIP/Postal Code

682-714

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Sun Yoon

Phone

82-52-250-7010

12. IPD Sharing Statement

Learn more about this trial

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

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