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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004100
First received: December 10, 1999
Last updated: December 17, 2013
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: vinorelbine tartrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Gemcitabine and Vinorelbine vs Standard Chemotherapy Containing Cisplatin for Stage IIIB/IV Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1998
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

Ages Eligible for Study:   up to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004100

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

Additional Information:
Publications:
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.
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.

ClinicalTrials.gov Identifier: NCT00004100     History of Changes
Other Study ID Numbers: CDR0000067316, ITA-GEMVIN, CAN-NCIC-BR14, EU-99016
Study First Received: December 10, 1999
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Vinorelbine
Cisplatin
Vinblastine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on July 23, 2014