Overview

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)