Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLC

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175381
• Other study ID #: CT/10.04
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 21, 2014
• Last updated: May 14, 2015
• Start date: February 2011
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• Carboplatin
Carboplatin: 2.5 AUC i.v on day 1. Cycle repeated ever 2 weeks
• Gemcitabine
Gemcitabine: 1100 mg/m2, iv on day 1. Cycle repeated every 2 weeks

Locations

Country	Name	City	State
Greece	"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Athens
Greece	401 Military Hospital of Athens	Athens
Greece	Air Forces Military Hospital of Athens Athens, Greece	Athens
Greece	Medical Oncology Unit NIMTS (Veterans Hospital)	Athens
Greece	University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece	Heraklion	Crete

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate		Disease evaluation at Week 8	No
Secondary	Disease control rate	Disease control rate is defined as the proportion of patients with complete response or partial response or stable disease for at least 16 weeks	Disease evaluation at Week 8	No
Secondary	Progression Free Survival		1 year	No
Secondary	Overall Survival		1 year	No
Secondary	Safety Profile	Patients will be evaluated for Adverse Events (related or unrelated to the treatment) on Day 1 of each cycle (cycle repeated every 2 weeks) up to 12 weeks from the date of first dose administration	Every two weeks up to 12 weeks	Yes