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

NCT00004100 | Unknown Phase 3

• 4 other identifiers: CDR0000067316ITA-GEMVINCAN-NCIC-BR14EU-99016
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 29

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.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Interventions

cisplatin DRUG

gemcitabine hydrochloride DRUG

vinorelbine tartrate DRUG

Eligibility Criteria

• Age: Up to 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Istituto Nazionale per lo Studio e la Cura dei Tumori: lead
• NCIC Clinical Trials Group: collaborator

Study Sites (29)

Ospedale San Lazzaro

Alba, 12051, Italy

Location

Ospedale Civile Avellino

Avellino, Italy

Location

Ospedale G. Di Maria - Avola (SR)

Avola (SR), Italy

Location

Azienda Ospedaliena G. Rummo

Benevento, 82100, Italy

Location

Ospedale Cardarelli - Campobasso

Campobasso, Italy

Location

Ospedale Civile Cosenza

Cosenza, 87100, Italy

Location

Ospedale San Martino/Cliniche Universitarie Convenzionate

Genoa, 16132, Italy

Location

Ospedale Gen. Provinciale Santa Maria Goretti

Latina, 04100, Italy

Location

Ospedale di Legnano

Legnano, 20025, Italy

Location

Ospedale Maggiore Lodi

Lodi, I-20075, Italy

Location

Ospedale Di Gabargnate Milanese

Milan, 20024, Italy

Location

Ospedale San Carlo Borromeo

Milan, 20153, Italy

Location

Istituto Di Science Biomediche San Paolo

Milan, 20142, Italy

Location

Federico II University Medical School

Naples, 80131, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, 80131, Italy

Location

Ospedale S. Gennora USL 42

Naples, 80136, Italy

Location

Ospedale Vincenzo Monaldi

Napoli, 80131, Italy

Location

ASL 2 - Napoli

Napoli, Italy

Location

Universita di Palermo

Palermo, 90141, Italy

Location

Ospedale La Maddalena - Palermo

Palermo, Italy

Location

Ospedale S. Francesco - Paola

Paola (CS), Italy

Location

Ospedale Agnelli

Pinerolo, 10064, Italy

Location

Ospedale San Carlo

Potenza, 85100, Italy

Location

Ospedali Riuniti

Reggio Calabria, 89100, Italy

Location

U.S.S.L. 33

Rho, Italy

Location

Ospedale Oncologieo G. Fortunato

Rionero Sannitico, Italy

Location

Istituti Fisioterapici Ospitalieri - Roma

Rome, 00161, Italy

Location

Ospedale Civile - Rovereto

Rovereto, Italy

Location

Ospedale San Bortolo

Vicenza, 36100, Italy

Location

Related Publications (3)

• 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.

  BACKGROUND

• 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.

  PMID: 12837810 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Cesare Gridelli, MD

  Istituto Nazionale per lo Studio e la Cura dei Tumori

  STUDY CHAIR

• Vera Hirsh, MD, FRCPC

  Royal Victoria Hospital - Montreal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: April 16, 2004
• Study Start: November 1, 1998
• Last Updated: December 18, 2013

Record last verified: 2008-06

Locations

IT (29)