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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
carboplatin
docetaxel
gemcitabine hydrochloride
paclitaxel
vinorelbine tartrate
Sponsored by
Japan Multinational Trial Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Nagoya University Hospital
  • Asahikawa Medical College
  • National Cancer Center Hospital East
  • National Hospital Organization - Ehime National Hospital
  • Aso Iizuka Hospital
  • National Hospital Organization - Medical Center of Kure
  • National Hospital Organization - Dohoku National Hospital
  • Fujisawa City Hospital
  • National Hospital Organization - Kochi Hospital
  • Kyoto-Katsura Hospital
  • Ogaki Municipal Hospital
  • National Hospital Organization - Okayama Medical Center
  • National Hospital Organization - Okinawa Hospital
  • Osaka General Medical Center
  • Osaka Saiseikai Nakatsu Hospital
  • Takatsuki Red Cross Hospital
  • National Hospital Organization - Osaka National Hospital
  • Saitama Cancer Center
  • Takamatsu Red Cross Hospital
  • Tokyo Medical and Dental University
  • Tokyo Medical University
  • Tottori University Hospital
  • Toyama Medical and Pharmaceutical University Hospital
  • Koseiren Takaoka Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2004
Last Updated
September 16, 2013
Sponsor
Japan Multinational Trial Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00079287
Brief Title
Vinorelbine, Gemcitabine, and Docetaxel Compared With Paclitaxel and Carboplatin in Treating Patients With Advanced Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
April 2005
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Multinational Trial Organization

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
vinorelbine tartrate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaaki Kawahara, MD
Organizational Affiliation
National Hospital Organization Osaka National Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Nagoya University Hospital
City
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Asahikawa Medical College
City
Asahikawa
ZIP/Postal Code
078 8510
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Chiba-ken
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization - Ehime National Hospital
City
Ehime
ZIP/Postal Code
791-0281
Country
Japan
Facility Name
Aso Iizuka Hospital
City
Fukuoka
ZIP/Postal Code
820-0018
Country
Japan
Facility Name
National Hospital Organization - Medical Center of Kure
City
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Facility Name
National Hospital Organization - Dohoku National Hospital
City
Hokkaido
ZIP/Postal Code
070-0901
Country
Japan
Facility Name
Fujisawa City Hospital
City
Kanagawa
ZIP/Postal Code
251-8550
Country
Japan
Facility Name
National Hospital Organization - Kochi Hospital
City
Kochi-shi
ZIP/Postal Code
780-8065
Country
Japan
Facility Name
Kyoto-Katsura Hospital
City
Kyoto
ZIP/Postal Code
615-8256
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki-shi
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
National Hospital Organization - Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
National Hospital Organization - Okinawa Hospital
City
Okinawa
ZIP/Postal Code
901-2214
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka-shi
ZIP/Postal Code
558-0056
Country
Japan
Facility Name
Osaka Saiseikai Nakatsu Hospital
City
Osaka
ZIP/Postal Code
530-0012
Country
Japan
Facility Name
Takatsuki Red Cross Hospital
City
Osaka
ZIP/Postal Code
569-1096
Country
Japan
Facility Name
National Hospital Organization - Osaka National Hospital
City
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0803
Country
Japan
Facility Name
Takamatsu Red Cross Hospital
City
Takamatsu
ZIP/Postal Code
760-8571
Country
Japan
Facility Name
Tokyo Medical and Dental University
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Tokyo Medical University
City
Tokyo
ZIP/Postal Code
160
Country
Japan
Facility Name
Tottori University Hospital
City
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Toyama Medical and Pharmaceutical University Hospital
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Facility Name
Koseiren Takaoka Hospital
City
Toyama
ZIP/Postal Code
933-8555
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
19231158
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 cancer: an analysis of Japan Multinational Trial Organisation LC00-03. Eur J Cancer. 2009 Jul;45(11):1950-8. doi: 10.1016/j.ejca.2009.01.023. Epub 2009 Feb 21.
Results Reference
result
PubMed Identifier
19013107
Citation
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 advanced non-small-cell lung cancer: a randomised, open-label, phase III study. Lancet Oncol. 2008 Dec;9(12):1135-42. doi: 10.1016/S1470-2045(08)70261-4. Epub 2008 Nov 13.
Results Reference
result
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.
Results Reference
result

Learn more about this trial

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

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