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Vinorelbine Versus Gemcitabine Versus Gemcitabine and Vinorelbine in Elderly Patients With Stage IIIB-IV Non-Small Cell Lung Cancer

Phase 3
70 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Vinorelbine Versus Gemcitabine Versus Gemcitabine and Vinorelbine in Elderly Patients With Stage IIIB-IV Non-Small Cell Lung Cancer

OBJECTIVES: I. Determine the activity and toxicities of gemcitabine in elderly patients with
non-small cell lung cancer. II. Determine the activity and toxicity of the combination of
gemcitabine and vinorelbine in these patients. III. Compare the survival rate and quality of
life of these patients treated with combination chemotherapy versus single agent
chemotherapy. IV. Compare objective response and time to progression of these patients
treated with these chemotherapy regimens. V. Compare the toxicities of these three regimens
in these patients. VI. Compare the number of hospitalizations, palliative radiation
therapies, antibiotic therapies, corticosteroid therapies, analgesic therapies, and
hematopoietic growth factor therapies needed for these patients treated with these
chemotherapy regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, stage
of disease (IIIB vs IV), and performance status (0 vs 1 vs 2). Patients are randomized to
one of three treatment arms. Patients receive either vinorelbine IV, gemcitabine IV, or both
on days 1 and 8 of each 21 day course. Patients who achieve an objective response or stable
disease after 3 courses receive 3 more courses (for a total of 6 courses). Quality of life
is assessed before treatment, after course 4 (or 3 weeks after course 3, if therapy is
stopped), and at 21 days after course 6 (or 12 weeks after course 3).

PROJECTED ACCRUAL: A total of 630 patients (210 patients per arm) will be accrued for this

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven non-small cell lung cancer
Stage IV OR Stage IIIB that has supraclavicular lymph node metastases or has pleural
deposits and is not curable with surgery or radical radiotherapy No brain metastases
suspected clinically or demonstrated radiologically

PATIENT CHARACTERISTICS: Age: 70 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Neutrophil count at least 2000/mm3 Platelet count at least
100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: (Unless caused by tumor) Bilirubin no
greater than 1.25 times upper limit of normal (ULN) SGOT or SGPT no greater than 1.25
times ULN Renal: Creatinine no greater than 1.5 mg/dL Other: No other serious medical
illness No prior or concurrent malignancy except curatively treated basal cell or squamous
cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: No prior chemotherapy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Cesare Gridelli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Istituto Nazionale per lo Studio e la Cura dei Tumori


United States: Federal Government

Study ID:




Start Date:

July 1998

Completion Date:

Related Keywords:

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