A phase I study of Docetaxel-Gefitinib for patients with gefitinib refractory non-small cell lung cancer

UMIN ID: UMIN000001338

Registered date:01/09/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 2008/08/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients will receive an infusion of docetaxel(40-60mg/m2) starting within 4 days of registration, every 3 weeks. Patients also continue to receive daily gefitinib orally.

Outcome(s)

• Primary Outcome: DLT(dose limiting toxicity),MTD(maximum tolerated dose),RD(recommended dose)
• Secondary Outcome: Safety, Response

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients were excluded if they had docetaxel treatment, any active concomitant malignancies, symptomatic brain metastases, past history of severe allergic reactions to drugs,interstitial pneumonia identified by chest CT, superior vena cava syndrome, or other serious complications, such as uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure, uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural effusion or ascites.

Related Information

• Primary Sponsor: Niigata Lung Cancer Treatment Group
• Source(s) of Monetary Support: none