Completed

Vinorelbine, Gemcitabine, and Docetaxel Compared With Paclitaxel and Carboplatin in Treating Patients With Advanced Non-Small Cell Lung Cancer

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What is being tested

carboplatin

+ docetaxel
+ gemcitabine hydrochloride
Drug
Who is being recruted

Lung Cancer

Over 18 Years
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2001

Summary

Principal SponsorJapan Multinational Trial Organization
Last updated: September 17, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2001Actual date on which the first participant was enrolled.

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. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying how well giving vinorelbine together with gemcitabine and docetaxel works compared to giving paclitaxel together with carboplatin in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. 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 overall survival of patients treated with these regimens. Secondary * 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.

Official TitlePhase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer 
Principal SponsorJapan Multinational Trial Organization
Last updated: September 17, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lung Cancer
Criteria

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)



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 24 locations
Suspended
Nagoya University HospitalAichi, JapanSee the location
Suspended
Asahikawa Medical CollegeAsahikawa, Japan
Suspended
National Cancer Center Hospital EastChiba-ken, Japan
Suspended
National Hospital Organization - Ehime National HospitalEhime, Japan

Completed24 Study Centers