Randomized phase II trial of docetaxel and carboplatin in patients with stage IIIB/IV non-small cell lung cancer.

UMIN ID: UMIN000001225

Registered date:01/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Stage IIIB/IV non-small cell lung cancer
• Date of first enrollment: 2007/06/01
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

docetaxel 60mg/m2, day1 + carboplatin AUC 6mg/mLxmin, day 1 q3w, 6 cycles
paclitaxel 200mg/m2, day1 + carboplatin AUC 6mg/mLxmin, day 1 q3w, 6 cycles

Outcome(s)

• Primary Outcome: Progression-free survival (PFS)
• Secondary Outcome: Response rate, 1-yr survival, overall survival, safety

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Patients with serious infections or suspected infections with fever. 2)Pregnant or lactating women 3)Active concomitant malignancy 4)Past history of allergic reactions to polysorbate 80 5)Patients with interstitial pneumonia or pulmonary fibrosis, as determined by chest x-ray 6)Patients with inadequately controlled complications such as hypertension, congestive heart failure, myocardial infarction, arrhythmia, bleeding and diabetes. 7)Clinically significant pleural/pericardial effusion which requires treatment 8)Symptomatic brain metastases 9)Grade 2 or greater peripheral neuropathy 10)Patients judged by the investigator as unfit to be enrolled in the study

Related Information

• Primary Sponsor: The Japan-multinational Trial Organization
• Source(s) of Monetary Support: The Japan-multinational Trial Organization