Skip to main content
OpenTrials
Completed

NCT Number: NCT00881296

Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer

A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly gemcitabine in elder patients (> 75) with previously untreated advanced non-small cell lung cancer. Primary objective is to determine the objective response rate (CR+PR by RECIST criteria) for biweekly gemcitabine and carboplatin combination chemotherapy versus weekly single gemcitabine as first-line therapy in elder advanced non-small lung cancer patients (> 76 years) who have received no prior treatment for non-small lung cancer. As secondary objectives, adverse event profile, tolerability of biweekly gemcitabine and carboplatin combination chemotherapy, progression-free survival and overall survival will be evaluated in both patients with biweekly gemcitabine and carboplatin combination chemotherapy and weekly single gemcitabine.

The study hypothesis is that biweekly combination chemotherapy of gemcitabine plus carboplatin may improve the efficacy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

76 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of histologically confirmed stage IIIB or IV non-small cell lung cancer
  • Good performance status (ECOG 0-1)
  • No previous treatment
  • Age 76 years and older
  • Adequate bone marrow, liver and renal functions
  • No pregnant
  • Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as >=1.0 cm by spiral CT scan
  • Provided written informed consent

Exclusion criteria

  • Severe complications or a concomitant malignancy
  • Prior and other concurrent radiotherapy, chemotherapy, immunotherapy, EGFR tyrosine kinase inhibitors
  • Interstitial pneumonia or lung fibrosis
  • Contraindicated gemcitabine or carboplatin
  • Inappropriate patients for entry to this study, judged by the physicians

Treatment and study plan

gemcitabine and carboplatin

Drug

Gemcitabine 1000mg/m2, DIV on day 1 and 15 of each 28 day cycle. Carboplatin AUC=3, DIV on day 1 and 15 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops, up to 6 cycles.

Gemcitabine

Drug

Gemcitabine 1000mg/m2, DIV on day 1, 8 and 15 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops, up to 6 cycles

Primary outcomes

  1. Efficacy (response rate)

    Time frame: two-years, followed RECIST criteria

Secondary outcomes

  1. The toxicity profile (adverse event profile)

    Time frame: two-years, followed NCI-CTCAE criteria

Sponsors and collaborators

Lead sponsor

Hamamatsu University

Other

Registry information

Official study title

Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer

Acronym: GEEP

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2009
Registry last updated
Sep 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.