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


Phase 2
70 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Time Frame:

every two cycles

Safety Issue:

No

Authority:

South Korea: Institutional Review Board

Study ID:

UUH-ONC-0019

NCT ID:

NCT00625352

Start Date:

February 2008

Completion Date:

Related Keywords:

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

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