Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLC

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

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.

Study Overview

• Status: Completed
• Conditions: NSCLC
• Intervention / Treatment: Drug: Carboplatin; Drug: Gemcitabine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Greece
  • Athens, 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)
  • Crete
    • Heraklion, Crete, Greece
      • University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carbo/GEM	Drug: Carboplatin; Carboplatin: 2.5 AUC i.v on day 1. Cycle repeated ever 2 weeks; Drug: Gemcitabine; Gemcitabine: 1100 mg/m2, iv on day 1. Cycle repeated every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Response Rate	Disease evaluation at Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival		1 year
Progression Free Survival		1 year
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
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

Collaborators and Investigators

• Sponsor: Hellenic Oncology Research Group

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 21, 2014
• First Submitted That Met QC Criteria: June 25, 2014
• First Posted (Estimate): June 26, 2014

Study Record Updates

• Last Update Posted (Estimate): May 15, 2015
• Last Update Submitted That Met QC Criteria: May 14, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Elderly; 1st Line; Metastatic NSCLC; Platinum-based treatment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine; Carboplatin
• Other Study ID Numbers: CT/10.04