Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Recruitment status was Active, not recruiting
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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 |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: vinorelbine tartrate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 | |
| Ospedale San Lazzaro | |
| Alba, Italy, 12051 | |
| Ospedale Civile Avellino | |
| Avellino, Italy | |
| Ospedale G. Di Maria - Avola (SR) | |
| Avola (SR), Italy | |
| Azienda Ospedaliena G. Rummo | |
| Benevento, Italy, 82100 | |
| Ospedale Cardarelli - Campobasso | |
| Campobasso, Italy | |
| Ospedale Civile Cosenza | |
| Cosenza, Italy, 87100 | |
| Ospedale San Martino/Cliniche Universitarie Convenzionate | |
| Genoa, Italy, 16132 | |
| Ospedale Gen. Provinciale Santa Maria Goretti | |
| Latina, Italy, 04100 | |
| Ospedale di Legnano | |
| Legnano, Italy, 20025 | |
| Ospedale Maggiore Lodi | |
| Lodi, Italy, I-20075 | |
| Ospedale Di Gabargnate Milanese | |
| Milan, Italy, 20024 | |
| Ospedale San Carlo Borromeo | |
| Milan, Italy, 20153 | |
| Istituto Di Science Biomediche San Paolo | |
| Milano, Italy, 20142 | |
| Federico II University Medical School | |
| Naples, Italy, 80131 | |
| Ospedale S. Gennora USL 42 | |
| Naples, Italy, 80136 | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Naples, Italy, 80131 | |
| Ospedale Vincenzo Monaldi | |
| Napoli, Italy, 80131 | |
| ASL 2 - Napoli | |
| Napoli, Italy | |
| Ospedale La Maddalena - Palermo | |
| Palermo, Italy | |
| Universita di Palermo | |
| Palermo, Italy, 90141 | |
| Ospedale S. Francesco - Paola | |
| Paola (CS), Italy | |
| Ospedale Agnelli | |
| Pinerolo, Italy, 10064 | |
| Ospedale San Carlo | |
| Potenza, Italy, 85100 | |
| Ospedali Riuniti | |
| Reggio Calabria, Italy, 89100 | |
| U.S.S.L. 33 | |
| Rho, Italy | |
| Ospedale Oncologieo G. Fortunato | |
| Rionero, Italy | |
| Istituti Fisioterapici Ospitalieri - Roma | |
| Rome, Italy, 00161 | |
| Ospedale Civile - Rovereto | |
| Rovereto, Italy | |
| Ospedale San Bortolo | |
| Vicenza, Italy, 36100 | |
| 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
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00004100 History of Changes |
| Other Study ID Numbers: | CDR0000067316, ITA-GEMVIN, CAN-NCIC-BR14, EU-99016 |
| Study First Received: | December 10, 1999 |
| Last Updated: | February 26, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Vinorelbine Cisplatin Vinblastine Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents |
ClinicalTrials.gov processed this record on May 16, 2013