A Phase 1/2 interventional study of Carboplatin and Gemcitabine in NSCLC, sponsored by Hellenic Oncology Research Group. Completed at 5 sites in Greece. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2015-05-15.
Sponsored by Hellenic Oncology Research Group · Phase 1/2, Interventional, and Treatment
The investigators propose to study the safety and efficacy of the combination of Carboplatin plus Gemcitabine in a Phase I/II trial of elderly subjects with non-small cell lung cancer.
About 50% of newly diagnosed cases of NSCLC concern patients older than 65 years, while 30-40% of cases are diagnosed in patients older than 70 years. Furthermore, recent data suggest that during the last decade, the incidence and mortality of NSCLC has decreased in younger patients, while it has increased among older patients. Based on these observations, it becomes clear that NSCLC represents a significant health problem in elderly patients. However, elderly patients are frequently underrepresented in clinical trials evaluating new treatments in NSCLC. Indeed, more than 75% of patients older than 65 years with metastatic NSCLC never receive any kind of chemotherapy in the daily clinical practice.
In elderly patients there is lack of prospective data regarding the role of platinum-based doublets. It is not clear whether elderly patients gain any survival benefit or not from platinum-based doublets and whether these chemotherapeutic regimens result in a significant increase in toxicity.
There is a clear need to prospectively evaluate the tolerability and efficacy of platinum-based doublets as first-line chemotherapy for older NSCLC patients.
On this basis it would be very interesting to initiate a phase I/II study with gemcitabine/carboplatin combination as first line treatment in older NSCLC patients.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 69 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Hellenic Oncology Research Group is the lead sponsor of 57 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Carboplatin · Drug: Gemcitabine
Carboplatin: 2.5 AUC i.v on day 1. Cycle repeated ever 2 weeks
Gemcitabine: 1100 mg/m2, iv on day 1. Cycle repeated every 2 weeks
Overall Response Rate
Time frame: Disease evaluation at Week 8
Disease control rate
Disease control rate is defined as the proportion of patients with complete response or partial response or stable disease for at least 16 weeks
Time frame: Disease evaluation at Week 8
Progression Free Survival
Time frame: 1 year
Overall Survival
Time frame: 1 year
Safety Profile
Patients will be evaluated for Adverse Events (related or unrelated to the treatment) on Day 1 of each cycle (cycle repeated every 2 weeks) up to 12 weeks from the date of first dose administration
Time frame: Every two weeks up to 12 weeks
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Hellenic Oncology Research Group