NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000136

Registered date:08/09/2005

phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedlung adenocarcinoma
Date of first enrollment2004/12/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Patients receive oral 250-mg gefitinib daily until disease progression.

Outcome(s)

Primary OutcomePrimary endpoint: response rate. Secondary endpoints: disease control rate, overall survival, time to progression, and toxicity.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum70years-old
Age maximumNot applicable
GenderMale and Female
Include criteria1) primary lung adenocarcinoma; 2) stage IIIB or IV disease, unsuitable for radical thoracic radiation; 3) age of 70 years or older; 4) Eastern Cooperative Oncology Group performance status of 0 to 2; 5) no prior chemotherapy; 6) measurable lesions; 7) adequate organ fanctions; and 8) written informed consent.
Exclude criteria1) interstitial pneumonitis or pulmonary fibrosis; 2) thoracic radiation within four weeks; 3) ongoing or planning palliative radiation; 4) symptomatic brain metastases; 5) uncontrolled pleural effusion; 6) pericardial effusion requiring drainage; 7) watery diarrhea; 8) serious underlying disease; 9) active concomitant malignancies; 10) a history of serious drug allergy; 11) clinically significant psychiatric disorder; and 12) unsuitable for entry to the study, decided by a medical oncologist.

Related Information

Contact

public contact
Name Masashi Kobayashi (secretariat)
Address 3-7-1 Habikino, Habikino-shi, Osaka 583-8588, Japan Japan
Telephone 0729-57-2121
E-mail
Affiliation Osaka Prefectural Medical Center for Respiratory and Allergic Diseases Department of Thoracic Malignancy
scientific contact
Name Kaoru Matsui (head), Masashi Kobayashi (secretariat)
Address 3-7-1 Habikino, Habikino-shi, Osaka 583-8588, Japan Japan
Telephone 0729-57-2121
E-mail
Affiliation Osaka Prefectural Medical Center for Respiratory and Allergic Diseases Department of Thoracic Malignancy