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

Lung Cancer Clinical Trial

Official title:

Gemcitabine and Vinorelbine vs Standard Chemotherapy Containing Cisplatin for Stage IIIB/IV Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00004100
• Other study ID #: CDR0000067316
• Secondary ID: ITA-GEMVINCAN-NC
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 10, 1999
• Last updated: December 17, 2013
• Start date: November 1998

Study information

• Verified date: June 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• cisplatin

• gemcitabine hydrochloride

• vinorelbine tartrate

Locations

Country	Name	City	State
Italy	Ospedale San Lazzaro	Alba
Italy	Ospedale Civile Avellino	Avellino
Italy	Ospedale G. Di Maria - Avola (SR)	Avola (SR)
Italy	Azienda Ospedaliena G. Rummo	Benevento
Italy	Ospedale Cardarelli - Campobasso	Campobasso
Italy	Ospedale Civile Cosenza	Cosenza
Italy	Ospedale San Martino/Cliniche Universitarie Convenzionate	Genoa
Italy	Ospedale Gen. Provinciale Santa Maria Goretti	Latina
Italy	Ospedale di Legnano	Legnano
Italy	Ospedale Maggiore Lodi	Lodi
Italy	Ospedale Di Gabargnate Milanese	Milan
Italy	Ospedale San Carlo Borromeo	Milan
Italy	Istituto Di Science Biomediche San Paolo	Milano
Italy	Federico II University Medical School	Naples
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Naples
Italy	Ospedale S. Gennora USL 42	Naples
Italy	ASL 2 - Napoli	Napoli
Italy	Ospedale Vincenzo Monaldi	Napoli
Italy	Ospedale La Maddalena - Palermo	Palermo
Italy	Universita di Palermo	Palermo
Italy	Ospedale S. Francesco - Paola	Paola (CS)
Italy	Ospedale Agnelli	Pinerolo
Italy	Ospedale San Carlo	Potenza
Italy	Ospedali Riuniti	Reggio Calabria
Italy	U.S.S.L. 33	Rho
Italy	Ospedale Oncologieo G. Fortunato	Rionero
Italy	Istituti Fisioterapici Ospitalieri - Roma	Rome
Italy	Ospedale Civile - Rovereto	Rovereto
Italy	Ospedale San Bortolo	Vicenza

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Nazionale per lo Studio e la Cura dei Tumori	Canadian Cancer Trials Group

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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 vin — View 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-Canadi

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.