Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer - Full Text View

Sponsored by:	Hamamatsu University
Information provided by:	Hamamatsu University
ClinicalTrials.gov Identifier:	NCT00881296

Purpose

A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly gemcitabine in elder patients (> 75) with previously untreated advanced non-small cell lung cancer. Primary objective is to determine the objective response rate (CR+PR by RECIST criteria) for biweekly gemcitabine and carboplatin combination chemotherapy versus weekly single gemcitabine as first-line therapy in elder advanced non-small lung cancer patients (> 76 years) who have received no prior treatment for non-small lung cancer. As secondary objectives, adverse event profile, tolerability of biweekly gemcitabine and carboplatin combination chemotherapy, progression-free survival and overall survival will be evaluated in both patients with biweekly gemcitabine and carboplatin combination chemotherapy and weekly single gemcitabine.

The study hypothesis is that biweekly combination chemotherapy of gemcitabine plus carboplatin may improve the efficacy.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: gemcitabine and carboplatin Drug: Gemcitabine	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer

Further study details as provided by Hamamatsu University:

Primary Outcome Measures:

Efficacy (response rate) [ Time Frame: two-years, followed RECIST criteria ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The toxicity profile (adverse event profile) [ Time Frame: two-years, followed NCI-CTCAE criteria ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Gemcitabine 1000mg/m2 Day 1,15 Carboplatin AUC=3 Day 1, 15 every 4 weeks	Drug: gemcitabine and carboplatin Gemcitabine 1000mg/m2, DIV on day 1 and 15 of each 28 day cycle. Carboplatin AUC=3, DIV on day 1 and 15 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops, up to 6 cycles.
2: Active Comparator Gemcitabine 1000mg/m2 Day 1, 8, 15	Drug: Gemcitabine Gemcitabine 1000mg/m2, DIV on day 1, 8 and 15 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops, up to 6 cycles

Eligibility

Ages Eligible for Study:	76 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of histologically confirmed stage IIIB or IV non-small cell lung cancer
Good performance status (ECOG 0-1)
No previous treatment
Age 76 years and older
Adequate bone marrow, liver and renal functions
No pregnant
Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as >=1.0 cm by spiral CT scan
Provided written informed consent

Exclusion Criteria:

Severe complications or a concomitant malignancy
Prior and other concurrent radiotherapy, chemotherapy, immunotherapy, EGFR tyrosine kinase inhibitors
Interstitial pneumonia or lung fibrosis
Contraindicated gemcitabine or carboplatin
Inappropriate patients for entry to this study, judged by the physicians

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881296

Contacts

Contact: Masato Karayama, MD

81-53-435-2263

may15@hama-med.ac.jp

Locations

Japan, Shizuoka
Hamamatsu University School of Medicine	Recruiting
Hamamatsu, Shizuoka, Japan, 431-3192
Contact: Karayama 81-53-435-2263

Sponsors and Collaborators

Hamamatsu University

Investigators

Study Chair:

Kingo Chida, MD,PhD

Hamamatsu University

More Information

No publications provided

Responsible Party:	Hamamatsu University School of Medicine ( Department of Respiratory Medicine )
Study ID Numbers:	Hamamatsu 20-34
Study First Received:	April 14, 2009
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00881296 History of Changes
Health Authority:	Japan: Institutional Review Board

Keywords provided by Hamamatsu University:

Elder Patients
Non-Small Cell Lung Cancer
Previously Untreated
Advanced

Study placed in the following topic categories:

Thoracic Neoplasms
Antimetabolites
Immunologic Factors
Carboplatin
Antiviral Agents
Immunosuppressive Agents
Carcinoma
Radiation-Sensitizing Agents

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Carboplatin
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009