Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer

NCT00881296 | Completed Phase 2 DMC

• 1 other identifier: Hamamatsu 20-34
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Elder Patients; Non-Small Cell Lung Cancer; Previously Untreated; Advanced

Outcome Measures

Primary Outcomes (1)

• Efficacy (response rate)

  two-years, followed RECIST criteria

Secondary Outcomes (1)

• The toxicity profile (adverse event profile)

  two-years, followed NCI-CTCAE criteria

Study Arms (2)

1

EXPERIMENTAL

Gemcitabine 1000mg/m2 Day 1,15 Carboplatin AUC=3 Day 1, 15 every 4 weeks

Drug: gemcitabine and carboplatin

2

ACTIVE COMPARATOR

Gemcitabine 1000mg/m2 Day 1, 8, 15

Drug: Gemcitabine

Interventions

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.

1

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

2

Eligibility Criteria

• Age: 76 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamamatsu University: lead

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Related Publications (1)

• Kusagaya H, Inui N, Karayama M, Nakamura Y, Kuroishi S, Yokomura K, Toyoshima M, Shirai T, Masuda M, Yamada T, Yasuda K, Suda T, Chida K. Biweekly combination therapy with gemcitabine and carboplatin compared with gemcitabine monotherapy in elderly patients with advanced non-small-cell lung cancer: a randomized, phase-II study. Lung Cancer. 2012 Sep;77(3):550-5. doi: 10.1016/j.lungcan.2012.05.106. Epub 2012 Jun 15.

  PMID: 22705118 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Kingo Chida, MD,PhD

  Hamamatsu University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Respiratory Medicine

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 15, 2009
• Study Start: March 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 7, 2011

Record last verified: 2010-05

Locations

JP (1)