Clinical trial NCT00004100: Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Official title: Gemcitabine and Vinorelbine vs Standard Chemotherapy Containing Cisplatin for Stage IIIB/IV Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: NCIC Clinical Trials Group
First posted: 2004-04-16
Sex: ALL
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Alba
country: Italy
facility: Ospedale San Lazzaro
city: Avellino
country: Italy
facility: Ospedale Civile Avellino
city: Avola (SR)
country: Italy
facility: Ospedale G. Di Maria - Avola (SR)
city: Benevento
country: Italy
facility: Azienda Ospedaliena G. Rummo
city: Campobasso
country: Italy
facility: Ospedale Cardarelli - Campobasso
city: Cosenza
country: Italy
facility: Ospedale Civile Cosenza
city: Genoa
country: Italy
facility: Ospedale San Martino/Cliniche Universitarie Convenzionate
city: Latina
country: Italy
facility: Ospedale Gen. Provinciale Santa Maria Goretti
city: Legnano
country: Italy
facility: Ospedale di Legnano
city: Lodi
country: Italy
facility: Ospedale Maggiore Lodi
city: Milano
country: Italy
facility: Istituto Di Science Biomediche San Paolo
city: Milan
country: Italy
facility: Ospedale Di Gabargnate Milanese
city: Milan
country: Italy
facility: Ospedale San Carlo Borromeo
city: Naples
country: Italy
facility: Federico II University Medical School
city: Naples
country: Italy
facility: Istituto Nazionale per lo Studio e la Cura dei Tumori
city: Naples
country: Italy
facility: Ospedale S. Gennora USL 42
city: Napoli
country: Italy
facility: Ospedale Vincenzo Monaldi
city: Napoli
country: Italy
facility: ASL 2 - Napoli
city: Palermo
country: Italy
facility: Universita di Palermo
city: Palermo
country: Italy
facility: Ospedale La Maddalena - Palermo
city: Paola (CS)
country: Italy
facility: Ospedale S. Francesco - Paola
city: Pinerolo
country: Italy
facility: Ospedale Agnelli
city: Potenza
country: Italy
facility: Ospedale San Carlo
city: Reggio Calabria
country: Italy
facility: Ospedali Riuniti
city: Rho
country: Italy
facility: U.S.S.L. 33
city: Rionero
country: Italy
facility: Ospedale Oncologieo G. Fortunato
city: Rome
country: Italy
facility: Istituti Fisioterapici Ospitalieri - Roma
city: Rovereto
country: Italy
facility: Ospedale Civile - Rovereto
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
Study officials:
affiliation: Istituto Nazionale per lo Studio e la Cura dei Tumori
name: Cesare Gridelli, MD
role: STUDY_CHAIR
affiliation: Royal Victoria Hospital - Montreal
name: Vera Hirsh, MD, FRCPC
role: STUDY_CHAIR
References:
citation: 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.
citation: 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. doi: 10.1200/JCO.2003.06.099. Epub 2003 Jul 1.
citation: 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.