Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLC

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Treatments: Carboplatin; Gemcitabine

Criteria

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)