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

December 17, 2013 updated by: Istituto Nazionale per lo Studio e la Cura dei Tumori

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alba, Italy, 12051
        • Ospedale San Lazzaro
      • Avellino, Italy
        • Ospedale Civile Avellino
      • Avola (SR), Italy
        • Ospedale G. Di Maria - Avola (SR)
      • Benevento, Italy, 82100
        • Azienda Ospedaliena G. Rummo
      • Campobasso, Italy
        • Ospedale Cardarelli - Campobasso
      • Cosenza, Italy, 87100
        • Ospedale Civile Cosenza
      • Genoa, Italy, 16132
        • Ospedale San Martino/Cliniche Universitarie Convenzionate
      • Latina, Italy, 04100
        • Ospedale Gen. Provinciale Santa Maria Goretti
      • Legnano, Italy, 20025
        • Ospedale di Legnano
      • Lodi, Italy, I-20075
        • Ospedale Maggiore Lodi
      • Milan, Italy, 20153
        • Ospedale San Carlo Borromeo
      • Milan, Italy, 20024
        • Ospedale Di Gabargnate Milanese
      • Milano, Italy, 20142
        • Istituto Di Science Biomediche San Paolo
      • Naples, Italy, 80131
        • Federico II University Medical School
      • Naples, Italy, 80131
        • Istituto Nazionale per lo Studio e la Cura dei Tumori
      • Naples, Italy, 80136
        • Ospedale S. Gennora USL 42
      • Napoli, Italy, 80131
        • Ospedale Vincenzo Monaldi
      • Napoli, Italy
        • ASL 2 - Napoli
      • Palermo, Italy
        • Ospedale La Maddalena - Palermo
      • Palermo, Italy, 90141
        • Università di Palermo
      • Paola (CS), Italy
        • Ospedale S. Francesco - Paola
      • Pinerolo, Italy, 10064
        • Ospedale Agnelli
      • Potenza, Italy, 85100
        • Ospedale San Carlo
      • Reggio Calabria, Italy, 89100
        • Ospedali Riuniti
      • Rho, Italy
        • U.S.S.L. 33
      • Rionero, Italy
        • Ospedale Oncologieo G. Fortunato
      • Rome, Italy, 00161
        • Istituti Fisioterapici Ospitalieri - Roma
      • Rovereto, Italy
        • Ospedale Civile - Rovereto
      • Vicenza, Italy, 36100
        • Ospedale San Bortolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 69 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale per lo Studio e la Cura dei Tumori

Collaborators

NCIC Clinical Trials Group

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1998

Study Registration Dates

First Submitted

December 10, 1999

First Submitted That Met QC Criteria

April 15, 2004

First Posted (Estimate)

April 16, 2004

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067316
  • ITA-GEMVIN
  • CAN-NCIC-BR14
  • EU-99016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe