NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001225

Registered date:01/07/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedStage IIIB/IV non-small cell lung cancer
Date of first enrollment2007/06/01
Target sample size90
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeProgression-free survival (PFS)
Secondary OutcomeResponse rate, 1-yr survival, overall survival, safety

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria1)written informed consent 2)histologically or cytologically confirmed stage IIIB (inoperable or ineligible for curative radiation therapy) or IV NSCLC with no prior chemotherapy. Recurrence after surgery is categorized as stage IV. 3)At least 3 weeks passed and recovered from toxicity from prior radiation therapy or surgery if applicable. 4)Measurable disease. 5)ECOG Performance status 0 or 1. 6)Adequate organ function (1) Neutrophil count >= 2,000/mm3 (2) Platelet count >= 100,000/mm3 (3) Hemoglobin >= 9.0g/dL (4) AST/ALT within twice the upper limit of normal (ULN) of institution (5) Total bilirubin within the ULN (6) Serum creatinine within the ULN (enzyme method) (7) Creatinine clearance >= 50 mL/min 7)PaO2 >= 70 torr or SpO2 >= 94% (room air) 8)Estimated life expectancy longer than 3 months
Exclude criteria1)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

Contact

public contact
Name
Address Japan
Telephone
E-mail
Affiliation The Japan-multinational Trial Organization The Japan-multinational Trial Organization
scientific contact
Name Masaaki KAWAHARA
Address 1_5_34 Otemae, chuo_ku, Osaka Japan
Telephone 06-6941-0484
E-mail
Affiliation Federation of National Public Sevice Personnel Mutual Aid Associations Otemae Hospital Medical Oncology