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Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information


Inclusion Criteria:



- Histological or cytological evidence of locally advanced, metastatic or recurrent
NSCLC (stage IIIB or Iv)

- At least one measurable lesion(s) by RECIST criteria

- No previous palliative chemotherapy

- Age 18 or higher.

- ECOG PS 0-2

- Life expectancy of at least 3 months.

- Adequate hematologic, hepatic, renal function

- Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul)

- Adequate liver function (≤ Total bilirubin ≤ 1.5 upper normal limit, ≤ AST/ALT x 2.5
upper normal limit, Alkaline phosphatase ≤ 2.5 upper normal limit)

- Adequate renal function (≤ serum creatinine 1.5 mg/dl)

- Written informed consent

Exclusion Criteria:

- No prior chemotherapy for NSCLC

- Patients with malignancies (other than NSCLC), except for adequately treated
nonmelanoma skin cancer or in situ carcinoma of the cervix.

- Peripheral neuropathy ≥ grade 2 (NCI CTC, version 3.0)

- Clinically significant cardiac disease (medically uncontrollable heart disease)

- Active infection or other serious medical illness

- Contraindication to any drug contained in the chemotherapy regimen

- Pregnant or lactating women were excluded.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Principal Investigator

Sun Young Kim, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chungnam National University Hospital

Authority:

South Korea: Institutional Review Board

Study ID:

GPM-0801

NCT ID:

NCT01023347

Start Date:

May 2008

Completion Date:

Related Keywords:

  • Non Small Cell Lung Cancer
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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