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A Phase II Study of Gemcitabine Plus Oxaliplatin for Patients With Advanced Stage IIIB or IV Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

A Phase II Study of Gemcitabine Plus Oxaliplatin for Patients With Advanced Stage IIIB or IV Non-Small Cell Lung Cancer

The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve
the therapeutic index. We are conducting a phase II study to evaluate the response rate and
toxicity of the gemcitabine-oxaliplatin combination both given every 4 weeks in patients
with advanced NSCLC.

Inclusion Criteria:

1. Histologic or cytologic diagnosis of NSCLC, Stage IV or selected stage IIIB (with
positive pleural effusion or separate tumor nodules in the same lobe) according to
the American Joint Committee on Cancer (AJCC).

2. No prior chemotherapy.

3. Prior radiation therapy is allowed as long as the irradiated area is not the only
source of measurable disease.

4. No other forms of cancer therapy, such as radiation, immunotherapy for at least 4
weeks before the enrollment in study.

5. Performance status of 0, 1, 2 on the ECOG criteria.

6. At least one unidimensional measurable lesion meeting Response Evaluation Criteria in
Solid Tumors (RECIST. 2000).

7. Estimated life expectancy of at least 12 weeks.

8. Patient compliance that allow adequate follow-up.

9. Adequate organ function including the following:Adequate hematologic function: WBC
count ≥ 3,500/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, and platelet count ≥
100,000/uLAdequate hepatic function: bilirubin ≤ 1.5 x UNL, ALT or AST ≤ 2.5 x
UNL.Adequate renal function: creatinine ≤ 1.5mg/dL.

10. Informed consent from patient

11. Males or females at least 18 years old.

12. If female: childbearing potential either terminated by surgery, radiation, or
menopause, or attenuated by use of an approved contraceptive method (intrauterine
device [IUD], birth control pills, or barrier device) during and for 3 months after
trial. If male, use of an approved contraceptive method during the study and 3 months
afterwards. Females with childbearing potential must have a urine negative hCG test
within 7 days prior to the study registration.

Exclusion Criteria:

1. MI within preceding 6 months or symptomatic heart disease, including unstable angina,
congestive heart failure or uncontrolled arrhythmia

2. Serious concomitant infection including post obstructive pneumonia

3. Second primary malignancy (except in situ carcinoma of the cervix or adequately
treated basal cell carcinoma of the skin or prior malignancy treated more than 5
years ago without recurrence)

4. Pregnant or nursing women

5. Psychiatric disorder that would preclude compliance.

6. Major surgery other than biopsy within the past two weeks.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

every 12 weeks during until disease progression

Safety Issue:


Principal Investigator

Heung Tae Kim, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

January 2006

Completion Date:

May 2011

Related Keywords:

  • Lung Cancer
  • Non small cell lung cancer
  • advanced stage IIIB
  • Stage IV
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms