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

Ulsan University Hospital

Status and phase

Unknown

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Gemcitabine, UFT

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00625352

UUH-ONC-0019

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No 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