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First Line Treatment of Stage IIIb/IV Non Small Cell (NSC) Lung Cancer With a Bimonthly Administration of a Combination of Cisplatin-Gemcitabine

Phase 2
18 Years
75 Years
Open (Enrolling)
Lung Cancer

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Trial Information

First Line Treatment of Stage IIIb/IV Non Small Cell (NSC) Lung Cancer With a Bimonthly Administration of a Combination of Cisplatin-Gemcitabine

OBJECTIVES: I. Determine the efficacy of the combination of cisplatin and gemcitabine in
terms of response rate and progression free survival in patients with stage IIIB or IV
non-small cell lung cancer. II. Evaluate this treatment regimen in terms of toxicity and
quality of life in these patients.

OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes and
cisplatin IV over 1 hour every 2 weeks for 6 courses in the absence of disease progression
or unacceptable toxicity. Patients with no disease progression following 6 courses of
therapy receive an additional 6 courses of therapy. Quality of life is assessed prior to
each course and then every 3 months. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 37-83 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer Locally advanced Stage IIIB (T4, Nx, M0, or Tx, N3, M0) OR Metastatic disease Stage
IV unresectable disease Following cell types eligible: Epidermoid cell Large cell
Adenocarcinoma Bidimensionally measurable disease Unresectable recurrence after primary
surgery allowed No brain metastasis

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: AST and ALT no greater than 3
times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN Renal:
Creatinine no greater than 1.10 mg/dL Cardiovascular: No uncontrolled cardiac disease
Other: No other significant, uncontrolled underlying medical or psychiatric condition No
serious active infection Neurologically stable No other prior malignancy except treated
nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
See Disease Characteristics Other: At least 30 days since prior experimental therapy No
other concurrent experimental drugs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Philippe Terrioux, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Clinique de Docteur Terrioux


United States: Federal Government

Study ID:




Start Date:

April 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms