Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004100
Recruitment Status : Unknown
Verified June 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : April 16, 2004
Last Update Posted : December 18, 2013
NCIC Clinical Trials Group
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: gemcitabine hydrochloride Drug: vinorelbine tartrate Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Vinorelbine

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004100

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
Istituto Di Science Biomediche San Paolo
Milano, Italy, 20142
Ospedale Di Gabargnate Milanese
Milan, Italy, 20024
Ospedale San Carlo Borromeo
Milan, Italy, 20153
Federico II University Medical School
Naples, Italy, 80131
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
Ospedale S. Gennora USL 42
Naples, Italy, 80136
Ospedale Vincenzo Monaldi
Napoli, Italy, 80131
ASL 2 - Napoli
Napoli, Italy
Universita di Palermo
Palermo, Italy, 90141
Ospedale La Maddalena - Palermo
Palermo, Italy
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
Sponsors and Collaborators
Istituto Nazionale per lo Studio e la Cura dei Tumori
NCIC Clinical Trials Group
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

Publications of Results:
Other Publications:
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. Identifier: NCT00004100     History of Changes
Other Study ID Numbers: CDR0000067316
First Posted: April 16, 2004    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: June 2008

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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic