Clinical trial NCT00881296: Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Elder Patients
Non-Small Cell Lung Cancer
Previously Untreated
Advanced
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2009-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 76
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Efficacy (response rate)
timeFrame: two-years, followed RECIST criteria
Secondary outcomes:
measure: The toxicity profile (adverse event profile)
timeFrame: two-years, followed NCI-CTCAE criteria
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
Study officials:
affiliation: Hamamatsu University
name: Kingo Chida, MD,PhD
role: STUDY_CHAIR
References:
citation: Kusagaya H, Inui N, Karayama M, Nakamura Y, Kuroishi S, Yokomura K, Toyoshima M, Shirai T, Masuda M, Yamada T, Yasuda K, Suda T, Chida K. Biweekly combination therapy with gemcitabine and carboplatin compared with gemcitabine monotherapy in elderly patients with advanced non-small-cell lung cancer: a randomized, phase-II study. Lung Cancer. 2012 Sep;77(3):550-5. doi: 10.1016/j.lungcan.2012.05.106. Epub 2012 Jun 15.