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

NCT ID: NCT00004100

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1998-11-30

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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cisplatin

Intervention Type DRUG

gemcitabine hydrochloride

Intervention Type DRUG

vinorelbine tartrate

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NCIC Clinical Trials Group

NETWORK

Sponsor Role collaborator

Istituto Nazionale per lo Studio e la Cura dei Tumori

OTHER

Sponsor Role lead

Principal Investigators

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Cesare Gridelli, MD

Role: STUDY_CHAIR

Istituto Nazionale per lo Studio e la Cura dei Tumori

Vera Hirsh, MD, FRCPC

Role: STUDY_CHAIR

Royal Victoria Hospital - Montreal

Locations

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Ospedale San Lazzaro

Alba, , Italy

Site Status

Ospedale Civile Avellino

Avellino, , Italy

Site Status

Ospedale G. Di Maria - Avola (SR)

Avola (SR), , Italy

Site Status

Azienda Ospedaliena G. Rummo

Benevento, , Italy

Site Status

Ospedale Cardarelli - Campobasso

Campobasso, , Italy

Site Status

Ospedale Civile Cosenza

Cosenza, , Italy

Site Status

Ospedale San Martino/Cliniche Universitarie Convenzionate

Genoa, , Italy

Site Status

Ospedale Gen. Provinciale Santa Maria Goretti

Latina, , Italy

Site Status

Ospedale di Legnano

Legnano, , Italy

Site Status

Ospedale Maggiore Lodi

Lodi, , Italy

Site Status

Ospedale Di Gabargnate Milanese

Milan, , Italy

Site Status

Ospedale San Carlo Borromeo

Milan, , Italy

Site Status

Istituto Di Science Biomediche San Paolo

Milan, , Italy

Site Status

Federico II University Medical School

Naples, , Italy

Site Status

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, , Italy

Site Status

Ospedale S. Gennora USL 42

Naples, , Italy

Site Status

Ospedale Vincenzo Monaldi

Napoli, , Italy

Site Status

ASL 2 - Napoli

Napoli, , Italy

Site Status

Universita di Palermo

Palermo, , Italy

Site Status

Ospedale La Maddalena - Palermo

Palermo, , Italy

Site Status

Ospedale S. Francesco - Paola

Paola (CS), , Italy

Site Status

Ospedale Agnelli

Pinerolo, , Italy

Site Status

Ospedale San Carlo

Potenza, , Italy

Site Status

Ospedali Riuniti

Reggio Calabria, , Italy

Site Status

U.S.S.L. 33

Rho, , Italy

Site Status

Ospedale Oncologieo G. Fortunato

Rionero Sannitico, , Italy

Site Status

Istituti Fisioterapici Ospitalieri - Roma

Rome, , Italy

Site Status

Ospedale Civile - Rovereto

Rovereto, , Italy

Site Status

Ospedale San Bortolo

Vicenza, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type 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.

Reference Type RESULT
PMID: 12837810 (View on PubMed)

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.

Reference Type RESULT

Other Identifiers

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ITA-GEMVIN

Identifier Type: -

Identifier Source: secondary_id

CAN-NCIC-BR14

Identifier Type: -

Identifier Source: secondary_id

EU-99016

Identifier Type: -

Identifier Source: secondary_id

CDR0000067316

Identifier Type: -

Identifier Source: org_study_id