Lung CancerPhase 3NCT00004100
Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
A Phase 3 study testing cisplatin, gemcitabine hydrochloride and vinorelbine tartrate in people with Lung Cancer, run by Istituto Nazionale per lo Studio e la Cura dei Tumori at 29 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages Up to 69 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- cisplatin, gemcitabine hydrochloride and vinorelbine tartrate
- How many people
- Not given
- Where
- 29 sitesItaly
- Study dates
- Nov 1998to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Italy29 sites
Ospedale San Lazzaro
Alba, 12051
Ospedale Civile Avellino
Avellino
Ospedale G. Di Maria - Avola (SR)
Avola (SR)
Azienda Ospedaliena G. Rummo
Benevento, 82100
Ospedale Cardarelli - Campobasso
Campobasso
Ospedale Civile Cosenza
Cosenza, 87100
Ospedale San Martino/Cliniche Universitarie Convenzionate
Genoa, 16132
Ospedale Gen. Provinciale Santa Maria Goretti
Latina, 04100
Ospedale di Legnano
Legnano, 20025
Ospedale Maggiore Lodi
Lodi, I-20075
Ospedale Di Gabargnate Milanese
Milan, 20024
Ospedale San Carlo Borromeo
Milan, 20153
Istituto Di Science Biomediche San Paolo
Milan, 20142
Federico II University Medical School
Naples, 80131
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, 80131
Ospedale Vincenzo Monaldi
Naples, 80131
Ospedale S. Gennora USL 42
Naples, 80136
ASL 2 - Napoli
Naples
Universita di Palermo
Palermo, 90141
Ospedale La Maddalena - Palermo
Palermo
Ospedale S. Francesco - Paola
Paola (CS)
Ospedale Agnelli
Pinerolo, 10064
Ospedale San Carlo
Potenza, 85100
Ospedali Riuniti
Reggio Calabria, 89100
U.S.S.L. 33
Rho
Ospedale Oncologieo G. Fortunato
Rionero Sannitico
Istituti Fisioterapici Ospitalieri - Roma
Rome, 00161
Ospedale Civile - Rovereto
Rovereto
Ospedale San Bortolo
Vicenza, 36100
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- cisplatin, gemcitabine hydrochloride, vinorelbine tartrate
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
vinorelbine tartrateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2004 (estimated)
- Study startNov 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale per lo Studio e la Cura dei Tumori
- Sponsor type
- University, hospital or other
- Collaborators
- NCIC Clinical Trials Group
- Investigators
- Cesare Gridelli, MD, Study chair, Istituto Nazionale per lo Studio e la Cura dei TumoriVera Hirsh, MD, FRCPC, Study chair, Royal Victoria Hospital - Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004100
- Sponsor's protocol ID
- CDR0000067316
- Other IDs
- ITA-GEMVIN, CAN-NCIC-BR14, EU-99016
- Status last verified
- Jun 2008
- First submitted
- 10 Dec 1999
- Last updated
- 18 Dec 2013
- Results posted
- No
Publications
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.
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.
PubMed 12837810Gridelli 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine and Vinorelbine vs Standard Chemotherapy Containing Cisplatin for Stage IIIB/IV Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00004100
- Acronym / sponsor ID
- CDR0000067316
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Istituto Nazionale per lo Studio e la Cura dei TumoriUniversity, hospital or other
- Collaborators
- NCIC Clinical Trials Group
- Study start
- Nov 1998
- First posted
- 16 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin | Drug | – |
| gemcitabine hydrochloride | Drug | – |
| vinorelbine tartrate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- BackgroundWheatley-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.
- Results publication: PubMed 12837810Gridelli 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.
- Results publicationGridelli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cesare Gridelli, MD study chair
Istituto Nazionale per lo Studio e la Cura dei Tumori
Vera Hirsh, MD, FRCPC study chair
Royal Victoria Hospital - Montreal
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatin, gemcitabine hydrochloride and vinorelbine tartrate in people with Lung Cancer, run by Istituto Nazionale per lo Studio e la Cura dei Tumori at 29 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004100, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.