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

Sponsor

Japan Multinational Trial Organization (Other)

Overall Status

Completed

CT.gov ID

NCT00079287

Collaborator

(none)

Locations

92.1

Duration (Months)

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: carboplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: vinorelbine tartrate	Phase 3

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 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2001

Actual Study Completion Date :

Nov 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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
5	Aso Iizuka Hospital	Fukuoka	Japan	820-0018
6	National Hospital Organization - Medical Center of Kure	Hiroshima	Japan	737-0023
7	National Hospital Organization - Dohoku National Hospital	Hokkaido	Japan	070-0901
8	Fujisawa City Hospital	Kanagawa	Japan	251-8550
9	National Hospital Organization - Kochi Hospital	Kochi-shi	Japan	780-8065
10	Kyoto-Katsura Hospital	Kyoto	Japan	615-8256
11	Ogaki Municipal Hospital	Ogaki-shi	Japan	503-8502
12	National Hospital Organization - Okayama Medical Center	Okayama	Japan	701-1192
13	National Hospital Organization - Okinawa Hospital	Okinawa	Japan	901-2214
14	Osaka General Medical Center	Osaka-shi	Japan	558-0056
15	Osaka Saiseikai Nakatsu Hospital	Osaka	Japan	530-0012
16	Takatsuki Red Cross Hospital	Osaka	Japan	569-1096
17	National Hospital Organization - Osaka National Hospital	Osaka	Japan	591-8555
18	Saitama Cancer Center	Saitama	Japan	362-0803
19	Takamatsu Red Cross Hospital	Takamatsu	Japan	760-8571
20	Tokyo Medical and Dental University	Tokyo	Japan	113-8519
21	Tokyo Medical University	Tokyo	Japan	160
22	Tottori University Hospital	Tottori	Japan	683-8504
23	Toyama Medical and Pharmaceutical University Hospital	Toyama	Japan	930-0194
24	Koseiren Takaoka Hospital	Toyama	Japan	933-8555