NCT02175381

Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLC

A Phase I/II Trial of the Carboplatin/Gemcitabine Combination as First Line Treatment for Elderly Patients With Stage IV NSCLC.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin: 2.5 AUC i.v on day 1. Cycle repeated ever 2 weeks
DRUG	Gemcitabine	Gemcitabine: 1100 mg/m2, iv on day 1. Cycle repeated every 2 weeks

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2014-06-26
• Last updated: 2015-05-15

Locations

5 sites across 1 country: Greece