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| Sponsors and Collaborators: |
Istituto Nazionale per lo Studio e la Cura dei Tumori National Cancer Institute of Canada |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004100 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
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Lung Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: vinorelbine ditartrate |
Phase III |
| MedlinePlus related topics: | Cancer Lung Cancer |
| ChemIDplus related topics: | Cisplatin Vinorelbine Vinorelbine tartrate Gemcitabine hydrochloride Gemcitabine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Gemcitabine and Vinorelbine vs Standard Chemotherapy Containing Cisplatin for Stage IIIB/IV Non-Small Cell Lung Cancer |
| Study Start Date: | November 1998 |
OBJECTIVES: I. Compare gemcitabine plus vinorelbine vs standard chemotherapy containing cisplatin in terms of the effect on the quality of life of patients with stage IIIB or IV non-small cell lung cancer. II. Compare the effect of these regimens on the overall survival of these patients. III. Compare the toxic effects of these regimens in these patients. IV. Compare the effect of these regimens on the rate of objective response in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, stage of disease (IIIB vs IV), and performance status (0 vs 1 vs 2). Patients are randomized to one of two treatment arms. Arm I: Patients receive cisplatin IV on day 1 and either gemcitabine IV or vinorelbine IV on days 1 and 8. Arm II: Patients receive gemcitabine IV and vinorelbine IV on days 1 and 8. Treatment repeats every 21 days for up to 6 courses. Quality of life is assessed prior to therapy and before each course of chemotherapy to the fourth course.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | up to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically proven non-small cell lung cancer Stage IV OR Stage IIIB with supraclavicular lymph node metastases and/or pleural effusion that is not curable with radiotherapy Measurable or evaluable disease No CNS metastases
PATIENT CHARACTERISTICS: Age: Under 70 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 2000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: (Unless caused by liver metastases) Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT or SGPT no greater than 1.25 times ULN Renal: Creatinine no greater than 1.25 times ULN Other: No prior or concurrent malignancy except basal or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Concurrent palliative radiotherapy allowed Surgery: Not specified
Contacts and Locations| Italy | |||||
| ASL 2 - Napoli | |||||
| Napoli, Italy | |||||
| Azienda Ospedaliena G. Rummo | |||||
| Benevento, Italy, 82100 | |||||
| Federico II University Medical School | |||||
| Naples, Italy, 80131 | |||||
| Istituti Fisioterapici Ospitalieri - Roma | |||||
| Rome, Italy, 00161 | |||||
| Istituto Di Science Biomediche San Paolo | |||||
| Milano, Italy, 20142 | |||||
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |||||
| Naples, Italy, 80131 | |||||
| Ospedale Agnelli | |||||
| Pinerolo, Italy, 10064 | |||||
| Ospedale Cardarelli - Campobasso | |||||
| Campobasso, Italy | |||||
| Ospedale Civile - Rovereto | |||||
| Rovereto, Italy | |||||
| Ospedale Civile Avellino | |||||
| Avellino, Italy | |||||
| Ospedale Civile Cosenza | |||||
| Cosenza, Italy, 87100 | |||||
| Ospedale Di Gabargnate Milanese | |||||
| Milan, Italy, 20024 | |||||
| Ospedale di Legnano | |||||
| Legnano, Italy, 20025 | |||||
| Ospedale G. Di Maria - Avola (SR) | |||||
| Avola (SR), Italy | |||||
| Universita di Palermo | |||||
| Palermo, Italy, 90141 | |||||
| Ospedale La Maddalena - Palermo | |||||
| Palermo, Italy | |||||
| Ospedale Maggiore Lodi | |||||
| Lodi, Italy, I-20075 | |||||
| Ospedale Oncologieo G. Fortunato | |||||
| Rionero, Italy | |||||
| Ospedale S. Francesco - Paola | |||||
| Paola (CS), Italy | |||||
| Ospedale S. Gennora USL 42 | |||||
| Naples, Italy, 80136 | |||||
| Ospedale San Bortolo | |||||
| Vicenza, Italy, 36100 | |||||
| Ospedale San Carlo | |||||
| Potenza, Italy, 85100 | |||||
| Ospedale San Carlo Borromeo | |||||
| Milan, Italy, 20153 | |||||
| Ospedale San Lazzaro | |||||
| Alba, Italy, 12051 | |||||
| Ospedale San Martino/Cliniche Universitarie Convenzionate | |||||
| Genoa, Italy, 16132 | |||||
| Ospedale Vincenzo Monaldi | |||||
| Napoli, Italy, 80131 | |||||
| Ospedali Riuniti | |||||
| Reggio Calabria, Italy, 89100 | |||||
| U.S.S.L. 33 | |||||
| Rho, Italy | |||||
| Ospedale Gen. Provinciale Santa Maria Goretti | |||||
| Latina, Italy, 04100 | |||||
| Istituto Nazionale per lo Studio e la Cura dei Tumori |
| National Cancer Institute of Canada |
| Study Chair: | Cesare Gridelli, MD | Istituto Nazionale per lo Studio e la Cura dei Tumori |
| Study Chair: | Vera Hirsh, MD, FRCPC | Royal Victoria Hospital - Montreal |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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Gridelli C, Gallo C, Shepherd FA, Illiano A, Piantedosi F, Robbiati SF, Manzione L, Barbera S, Frontini L, Veltri E, Findlay B, Cigolari S, Myers R, Ianniello GP, Gebbia V, Gasparini G, Fava S, Hirsh V, Bezjak A, Seymour L, Perrone F. Gemcitabine plus vinorelbine compared with cisplatin plus vinorelbine or cisplatin plus gemcitabine for advanced non-small-cell lung cancer: a phase III trial of the Italian GEMVIN Investigators and the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2003 Aug 15;21(16):3025-34. Epub 2003 Jul 1.
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| Gridelli C, Shepherd F, Perrone F, et al.: Gemvin III: a phase III study of gemcitabine plus vinorelbine (GV) compared to cisplatin plus vinorelbine or gemcitabine chemotherapy (PCT) for stage IIIb or IV non-small cell lung cancer (NSCLC): an Italo-Canadian study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1165, 2002. |
| Wheatley-Price P, Le Maître A, Ding K, et al.: The influence of sex on efficacy, toxicity and delivery of treatment in National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) non-small cell lung cancer (NSCLC) chemotherapy trials. [Abstract] J Clin Oncol 26 (Suppl 15): A-8054, 2008. |
| Study ID Numbers: | CDR0000067316, ITA-GEMVIN, CAN-NCIC-BR14, EU-99016 |
| First Received: | December 10, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004100 |
| Health Authority: | United States: Federal Government |
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