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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00079287
• Other study ID #: CDR0000355138
• Secondary ID: JMTO-LC00-03
• Status: Completed
• Phase: Phase 3
• First received: March 8, 2004
• Last updated: September 16, 2013
• Start date: March 2001
• Est. completion date: November 2008

Study information

• Verified date: April 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• carboplatin

• docetaxel

• gemcitabine hydrochloride

• paclitaxel

• vinorelbine tartrate

Locations

Country	Name	City	State
Japan	Nagoya University Hospital	Aichi
Japan	Asahikawa Medical College	Asahikawa
Japan	National Cancer Center Hospital East	Chiba-ken
Japan	National Hospital Organization - Ehime National Hospital	Ehime
Japan	Aso Iizuka Hospital	Fukuoka
Japan	National Hospital Organization - Medical Center of Kure	Hiroshima
Japan	National Hospital Organization - Dohoku National Hospital	Hokkaido
Japan	Fujisawa City Hospital	Kanagawa
Japan	National Hospital Organization - Kochi Hospital	Kochi-shi
Japan	Kyoto-Katsura Hospital	Kyoto
Japan	Ogaki Municipal Hospital	Ogaki-shi
Japan	National Hospital Organization - Okayama Medical Center	Okayama
Japan	National Hospital Organization - Okinawa Hospital	Okinawa
Japan	National Hospital Organization - Osaka National Hospital	Osaka
Japan	Osaka Saiseikai Nakatsu Hospital	Osaka
Japan	Takatsuki Red Cross Hospital	Osaka
Japan	Osaka General Medical Center	Osaka-shi
Japan	Saitama Cancer Center	Saitama
Japan	Takamatsu Red Cross Hospital	Takamatsu
Japan	Tokyo Medical and Dental University	Tokyo
Japan	Tokyo Medical University	Tokyo
Japan	Tottori University Hospital	Tottori
Japan	Koseiren Takaoka Hospital	Toyama
Japan	Toyama Medical and Pharmaceutical University Hospital	Toyama

Sponsors (1)

Lead Sponsor	Collaborator
Japan Multinational Trial Organization

Country where clinical trial is conducted

Japan, 

References & Publications (3)

Kubota K, Kawahara M, Ogawara M, Nishiwaki Y, Komuta K, Minato K, Fujita Y, Teramukai S, Fukushima M, Furuse K; Japan Multi-National Trial Organisation. Vinorelbine plus gemcitabine followed by docetaxel versus carboplatin plus paclitaxel in patients with — View Citation

Teramukai S, Kitano T, Kishida Y, Kawahara M, Kubota K, Komuta K, Minato K, Mio T, Fujita Y, Yonei T, Nakano K, Tsuboi M, Shibata K, Furuse K, Fukushima M. Pretreatment neutrophil count as an independent prognostic factor in advanced non-small-cell lung c — View Citation

Teramukai S, Nishimura T, Nakagawa M, et al.: Predictors and impacts of second-line chemotherapy on survival after progression in patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 25 (Suppl 18): A-7675, 2007.