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Phase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer

Phase 3
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Phase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer



- Compare the therapeutic effect of vinorelbine, gemcitabine, and docetaxel vs paclitaxel
and carboplatin in patients with advanced non-small cell lung cancer.

- Compare the overall survival of patients treated with these regimens.


- Compare the response rate in patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive vinorelbine IV and gemcitabine IV on days 1 and 8. Treatment
repeats every 21 days for 3 courses. Patients then receive docetaxel IV on day 1.
Treatment repeats every 21 days for 3 courses.

- Arm II: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats
every 21 days for 6 courses.

Patients are followed for 1 year.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this
study within 2 years.

Inclusion Criteria


- Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)
meeting criteria for 1 of the following:

- Newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural
effusion) disease

- Newly diagnosed stage IV disease

- Recurrent disease after prior surgery and/or radiotherapy

- The following cellular subtypes are allowed:

- Adenocarcinoma

- Large cell carcinoma

- Squamous cell carcinoma

- Unspecified carcinoma

- Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical examination, or
bone scintigraphy

- Pleural effusions, ascites, and laboratory parameters are not allowed as the
only evidence of disease

- Disease must be present outside area of prior surgical resection

- Disease must be present outside area of prior radiotherapy OR new lesion

- No known brain metastases by CT scan or MRI within the past 6 weeks

- No pleural or pericardial effusions requiring treatment



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL


- Bilirubin ≤ 2 times upper limit of normal (ULN)

- SGOT or SGPT ≤ 2 times ULN

- Alkaline phosphatase ≤ 2 times ULN


- Creatinine ≤ ULN

- Creatinine clearance ≥ 50 mL/min


- No uncontrolled hypertension

- No unstable angina

- No congestive heart failure

- No myocardial infarction within the past year

- No ventricular arrhythmia requiring medical intervention


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No prior allergic drug reaction attributed to Cremophor or polysorbate 80

- No disorder associated with lung cancer with life-threatening consequences

- No motor or sensory neuropathy ≥ grade 2

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission

- No uncontrolled diabetes


Biologic therapy

- No prior biologic therapy for NSCLC


- No prior systemic chemotherapy for NSCLC

Endocrine therapy

- No prior or concurrent steroid-type hormonal therapy (e.g., ethinyl estradiol)


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered


- See Disease Characteristics

- At least 2 weeks since prior thoracic or other major surgery and recovered


- No prior or concurrent azole antifungal therapy (e.g., ketoconazole, miconazole, or

- No prior or concurrent macrolides (e.g., erythromycin or clarithromycin)

- No prior or concurrent cyclosporine, terfenadine, benzodiazepines (e.g., diazepam,
triazolam, or midazolam), or retinoids

- No prior or concurrent calcium antagonists (e.g., diltiazem, nifedipine, or

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Masaaki Kawahara, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Hospital Organization - Osaka National Hospital


United States: Federal Government

Study ID:




Start Date:

March 2001

Completion Date:

Related Keywords:

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