Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Carboplatin

Antimetabolites

Gemcitabine 1000mg/m2 Day 1,15

Carboplatin AUC=3 Day 1, 15 every 4 weeks

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.

gemcitabine and carboplatin

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

Kingo Chida, MD,PhD

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.

Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer

Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer

Hamamatsu University

Department of Respiratory Medicine

Icotinib: 125mg, oral administration, three times per day.

Icotinib

Han Baohui, MD

A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

* Primary endpoint to assess progression-free survival
* Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.

First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients

An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation

PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.

Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive.

Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.

Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer	NCT00881296	Non-Small Cell ...	gemcitabine and... Gemcitabine	76 Years -	Hamamatsu University
First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients	NCT01646450	Non-Small Cell ...	Icotinib	70 Years - 80 Years	Betta Pharmaceuticals Co., Ltd.
First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients	NCT01646450	Non-Small Cell ...	Icotinib	70 Years - 80 Years	Betta Pharmaceuticals Co., Ltd.

Spots Global Cancer Trial Database for elder patients