Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLC

Hellenic Oncology Research Group

Status and phase

Completed

Phase 2

Phase 1

Conditions

NSCLC

Treatments

Drug: Carboplatin

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT02175381

CT/10.04

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥70 years old
Cytologically or histologically documented NSCLC
Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion)
World Health Organisation (WHO) performance status 0-2
Non-frail patients according to Comprehensive Geriatric Assessment
Previously treated NSCLC (or patients for whom the combination is considered adequate treatment) (for phase I part)
No prior chemotherapy (for phase II part)
Life expectancy of at least 12 weeks
Serum bilirubin less than 1.5 times the upper normal limit
Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit in the absence of demonstrable liver metastases, or less than 5 times the upper normal limit in the presence of liver metastases
Serum creatinine less than 1.5 times the upper normal limit and Creatinine Clearance >60 ml/min
Neutrophil count more than 1.5x 109 /L
Platelet count more than 100x 109 /L
Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations.

Exclusion criteria

Hemoptysis
Central nervous system metastases
Clinically significant cardiovascular disease
Medically uncontrolled hypertension
Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ)
Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)