Status:
COMPLETED
Vinorelbine, Gemcitabine, and Docetaxel Compared With Paclitaxel and Carboplatin in Treating Patients With Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Japan Multinational Trial Organization
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, gemcitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. C...
Detailed Description
OBJECTIVES: Primary * Compare the therapeutic effect of vinorelbine, gemcitabine, and docetaxel vs paclitaxel and carboplatin in patients with advanced non-small cell lung cancer. * Compare the over...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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 documented
- No known brain metastases by CT scan or MRI within the past 6 weeks
- No pleural or pericardial effusions requiring treatment
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Zubrod 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- SGOT or SGPT ≤ 2 times ULN
- Alkaline phosphatase ≤ 2 times ULN
- Renal
- Creatinine ≤ ULN
- Creatinine clearance ≥ 50 mL/min
- Cardiovascular
- No uncontrolled hypertension
- No unstable angina
- No congestive heart failure
- No myocardial infarction within the past year
- No ventricular arrhythmia requiring medical intervention
- Other
- 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
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior biologic therapy for NSCLC
- Chemotherapy
- No prior systemic chemotherapy for NSCLC
- Endocrine therapy
- No prior or concurrent steroid-type hormonal therapy (e.g., ethinyl estradiol)
- Radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- Surgery
- See Disease Characteristics
- At least 2 weeks since prior thoracic or other major surgery and recovered
- Other
- No prior or concurrent azole antifungal therapy (e.g., ketoconazole, miconazole, or itraconazole)
- 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 verapamil)
Exclusion
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
End Date :
November 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00079287
Start Date
March 1 2001
End Date
November 1 2008
Last Update
September 17 2013
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
Nagoya University Hospital
Aichi, Japan, 466-8560
2
Asahikawa Medical College
Asahikawa, Japan, 078 8510
3
National Cancer Center Hospital East
Chiba-ken, Japan, 277-8577
4
National Hospital Organization - Ehime National Hospital
Ehime, Japan, 791-0281