Vinorelbine and/or Gemcitabine in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

July 23, 2008

Start Date ^ICMJE

July 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00003447 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Vinorelbine and/or Gemcitabine in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Official Title ^ICMJE

Vinorelbine Versus Gemcitabine Versus Gemcitabine and Vinorelbine in Elderly Patients With Stage IIIB-IV Non-Small Cell Lung Cancer

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of vinorelbine, gemcitabine, or both in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Detailed Description

OBJECTIVES: I. Determine the activity and toxicities of gemcitabine in elderly patients with non-small cell lung cancer. II. Determine the activity and toxicity of the combination of gemcitabine and vinorelbine in these patients. III. Compare the survival rate and quality of life of these patients treated with combination chemotherapy versus single agent chemotherapy. IV. Compare objective response and time to progression of these patients treated with these chemotherapy regimens. V. Compare the toxicities of these three regimens in these patients. VI. Compare the number of hospitalizations, palliative radiation therapies, antibiotic therapies, corticosteroid therapies, analgesic therapies, and hematopoietic growth factor therapies needed for these patients treated with these chemotherapy regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, stage of disease (IIIB vs IV), and performance status (0 vs 1 vs 2). Patients are randomized to one of three treatment arms. Patients receive either vinorelbine IV, gemcitabine IV, or both on days 1 and 8 of each 21 day course. Patients who achieve an objective response or stable disease after 3 courses receive 3 more courses (for a total of 6 courses). Quality of life is assessed before treatment, after course 4 (or 3 weeks after course 3, if therapy is stopped), and at 21 days after course 6 (or 12 weeks after course 3).

PROJECTED ACCRUAL: A total of 630 patients (210 patients per arm) will be accrued for this study.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Drug: gemcitabine hydrochloride
Drug: vinorelbine ditartrate

Study Arms / Comparison Groups

Publications *

Gridelli C, Perrone F, Gallo C, Cigolari S, Rossi A, Piantedosi F, Barbera S, Ferrau F, Piazza E, Rosetti F, Clerici M, Bertetto O, Robbiati SF, Frontini L, Sacco C, Castiglione F, Favaretto A, Novello S, Migliorino MR, Gasparini G, Galetta D, Iaffaioli RV, Gebbia V; MILES Investigators. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst. 2003 Mar 5;95(5):362-72.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

630

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS: Histologically or cytologically proven non-small cell lung cancer Stage IV OR Stage IIIB that has supraclavicular lymph node metastases or has pleural deposits and is not curable with surgery or radical radiotherapy No brain metastases suspected clinically or demonstrated radiologically

PATIENT CHARACTERISTICS: Age: 70 and over 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 tumor) 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 1.5 mg/dL Other: No other serious medical illness No prior or concurrent malignancy except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: No prior chemotherapy

Gender

Both

Ages

70 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00003447

Responsible Party

Study ID Numbers ^ICMJE

CDR0000066476, ITA-MILES, ITA-GOCSI-MILES, EU-98019

Study Sponsor ^ICMJE

Istituto Nazionale per lo Studio e la Cura dei Tumori

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Cesare Gridelli, MD

Istituto Nazionale per lo Studio e la Cura dei Tumori

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP