A Phase II Study of TX Regimen as First-line Treatment for Asian Elderly Patients With Advanced Adenocarcinoma of Lung

Sponsor
Sun Yat-sen University
Study ID
NCT00816868
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib in combination with capecitabine — DRUG
    Erlotinib 150 mg Q.D. orally for 21 days plus Capecitabine 1000 mg/m2 twice daily for 2 weeks followed by 1 week break every 21 days Until PD, unacceptable toxicity or death.

Study Details

Because of the effect in the treatment of NSCLC, the capecitabine and erlotinib may compose to a new regimen for NSCLC. Based on the preclinical observation and the confirmed clinical synergistic anti-tumor activity of combined capecitabine and erlotinib in gemzar refractory advanced pancreatic cancer (APC), the investigators previously conducted a phase II study of erlotinib in combination with capecitabine against NSCLC.

Key Dates

First listed
Jan 5, 2009
Start date
Jan 31, 2009
Status verified
Feb 2012
Primary completion
May 31, 2010
Completion
Mar 31, 2011

Study Design

Enrollment
62 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: non-small cell lung cancer (NSCLC)
    erlotinib in combination with capecitabine as first-line treatment in elderly patients with stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC)

Primary Outcome Measure

Non-progression rate (CR + PR + SD) at week 12 and 18 [ Time Frame: 1 year ]

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