Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

— GEEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881296
• Other study ID #: Hamamatsu 20-34
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2009
• Last updated: September 5, 2011
• Start date: March 2008
• Est. completion date: June 2011

Study information

• Verified date: May 2010
• Source: Hamamatsu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 76 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• gemcitabine and carboplatin
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
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

Locations

Country	Name	City	State
Japan	Hamamatsu University School of Medicine	Hamamatsu	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (response rate)		two-years, followed RECIST criteria	Yes
Secondary	The toxicity profile (adverse event profile)		two-years, followed NCI-CTCAE criteria	Yes