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| Sponsored by: |
Japan Multinational Trial Organization |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00079287 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: vinorelbine ditartrate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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: | March 2001 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) meeting criteria for 1 of the following:
The following cellular subtypes are allowed:
Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical examination, or bone scintigraphy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| Japan | |
| Asahikawa Medical College | |
| Asahikawa, Japan, 078 8510 | |
| Aso Iizuka Hospital | |
| Fukuoka, Japan, 820-0018 | |
| Fujisawa City Hospital | |
| Kanagawa, Japan, 251-8550 | |
| Koseiren Takaoka Hospital | |
| Toyama, Japan, 933-8555 | |
| Kyoto-Katsura Hospital | |
| Kyoto, Japan, 615-8256 | |
| Nagoya University Hospital | |
| Aichi, Japan, 466-8560 | |
| National Cancer Center Hospital East | |
| Chiba-ken, Japan, 277-8577 | |
| National Hospital Organization - Medical Center of Kure | |
| Hiroshima, Japan, 737-0023 | |
| National Hospital Organization - Dohoku National Hospital | |
| Hokkaido, Japan, 070-0901 | |
| National Hospital Organization - Ehime National Hospital | |
| Ehime, Japan, 791-0281 | |
| National Hospital Organization - Kochi Hospital | |
| Kochi-shi, Japan, 780-8065 | |
| National Hospital Organization - Okayama Medical Center | |
| Okayama, Japan, 701-1192 | |
| Toyama Medical and Pharmaceutical University Hospital | |
| Toyama, Japan, 930-0194 | |
| National Hospital Organization - Osaka National Hospital | |
| Osaka, Japan, 591-8555 | |
| Ogaki Municipal Hospital | |
| Ogaki-shi, Japan, 503-8502 | |
| Osaka General Medical Center | |
| Osaka-shi, Japan, 558-0056 | |
| Osaka Saiseikai Nakatsu Hospital | |
| Osaka, Japan, 530-0012 | |
| Saitama Cancer Center | |
| Saitama, Japan, 362-0803 | |
| Takamatsu Red Cross Hospital | |
| Takamatsu, Japan, 760-8571 | |
| Takatsuki Red Cross Hospital | |
| Osaka, Japan, 569-1096 | |
| Tokyo Medical and Dental University | |
| Tokyo, Japan, 113-8519 | |
| Tokyo Medical University | |
| Tokyo, Japan, 160 | |
| Tottori University Hospital | |
| Tottori, Japan, 683-8504 | |
| National Hospital Organization - Okinawa Hospital | |
| Okinawa, Japan, 901-2214 | |
| Study Chair: | Masaaki Kawahara, MD | National Hospital Organization - Osaka National Hospital |
More Information
| Study ID Numbers: | CDR0000355138, JMTO-LC00-03 |
| Study First Received: | March 8, 2004 |
| Last Updated: | January 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00079287 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Thoracic Neoplasms Antimetabolites Immunologic Factors Vinblastine Docetaxel Respiratory Tract Diseases Lung Neoplasms Gemcitabine Carboplatin Antimitotic Agents Antiviral Agents Immunosuppressive Agents Recurrence |
Carcinoma Vinorelbine Radiation-Sensitizing Agents Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Vinblastine Docetaxel Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Gemcitabine |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Carboplatin Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Vinorelbine Radiation-Sensitizing Agents Paclitaxel Lung Diseases |