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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001338

Enrollment

Registered

2008-09-01

Start date

2008-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligibility criteria 1)histologically or cytologically confirmed NSCLC 2) postoperative recurrence or refractory unresectable III / IV (3)maximal effect was confirmed in PR or SD by RECIST criteria after Gefitinib administration, and progressed subsequently (continuing Gefitinib to registration). (4)no severe adverse event of Gefitib (except temporary interruption). (5)chemotherapy treatment history of the 1-2 regimen(except postoperative adjuvant chemotherapy). (6)20 years or older. (7)PS(ECOG) 0-1 (8)preserved major organ function leukocyte count >=3,000/mL, neutrophil count >=1,500/mL, hemoglobin concentration >=8g/dL, platelet count >=100,000/mL), kidney (creatinine=< 1.5x upper limit), liver (AST and ALT=< 2.0x upper limit), total bilirubin =< 1.5x upper limit, and pulmonary (PaO2 >= 60 torr) functions. (9)life expectancy more than 3 month (10)written informed consent

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
DLT(dose limiting toxicity),MTD(maximum tolerated dose),RD(recommended dose)	—

Secondary

Measure	Time frame
Safety, Response	—

Countries

Japan

Contacts

Public ContactHirohisa Yoshizawa

Niigata University Medical and Dental Hospital Bioscience Medical Research Center

hy0522@med.niigata-u.ac.jp025-227-2517

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026