Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLC

• Register: ClinicalTrials.gov
• Last refreshed on: 25 May 2015
• Main ID: NCT02175381
• Date of registration: 21/06/2014
• Prospective Registration: No
• Primary sponsor: Hellenic Oncology Research Group
• Public title: Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLC
• Scientific title: A Phase I/II Trial of the Carboplatin/Gemcitabine Combination as First Line Treatment for Elderly Patients With Stage IV NSCLC.
• Date of first enrolment: February 2011
• Target sample size: 69
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02175381
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Greece

Contacts

• Name: Athanasios Karambeazis, MD
• Affiliation: Medical Oncology Unit NIMTS (Veterans Hospital)

• Name: Lambros Vamvakas, MD
• Affiliation: University Hospital of Herklion

Key inclusion & exclusion 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)



Age minimum: 70 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

NSCLC

Intervention(s)

Drug: Carboplatin

Drug: Gemcitabine

Primary Outcome(s)

Overall Response Rate [Time Frame: Disease evaluation at Week 8]

Secondary Outcome(s)

Overall Survival [Time Frame: 1 year]

Safety Profile [Time Frame: Every two weeks up to 12 weeks]

Disease control rate [Time Frame: Disease evaluation at Week 8]

Progression Free Survival [Time Frame: 1 year]

Secondary ID(s)

CT/10.04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors