A combination phase II study of paclitaxel and gemcitabine for recurrent or relapsed non-small cell lung cancer previously treated with platinum or docetaxel-based regimen

A combination phase II study of paclitaxel and gemcitabine for recurrent or relapsed non-small cell lung cancer previously treated with platinum or docetaxel-based regimen - Phase II study of paclitaxel and gemcitabine for previously treated non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000219

Enrollment

Registered

2005-09-13

Start date

2001-12-01

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

The chemotherapy consisted of paclitaxel 150 mg/m2, iv, on day 1 ,and gemcitabine 1000 mg/m2, iv, on days 1 and 8. The treatment was repeated every 3 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-small cell lung cancer. 2) Stage IV or IIIB unsuitable for thoracic radiation. 3) Measurable lesions. Measurable lesions should exist outside of the radiation field. 4) Non-small cell lung cancer with previous chemotherapy containing platinum or docetaxel. One or two previous regimens are allowed. 5) Age4000/mm2; Hg>10.0g/dl; Platelet count>100,000/mm2; Total bilirubin65torr 8) Life expectancy of more than 3months. 9) No complication of serious heart and pulmonary diseases. 10) No active double cancer within 3 year. 11) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with lesions that can not judged for response by only chemotherapy. Patients previously treated with chemoradiotherapy are not allowed to be enrolled. 2) Active infectious disease and complications that affect the trial. 3) Apparent interstitial pneumonitis or fibrosis on chest X ray. 4) Symptomatic brain metastases. 5) Patients requiring pleural/ pericardial drainage. 6) Previous chemotherapy with gemcitabine or paclitaxel. 7) Allergy for a polyoxyethylene castor oil or a hardening castor oil component drug. 8) Woman who has a possibility of pregnancy. 9) Interval less than 30days from the last day of a previous treatment. 10) Other patients unsuitable for the study.

Design outcomes

Primary

Measure	Time frame
Response rate (according to RECIST criteria)	—

Secondary

Measure	Time frame
Adverse events, Survival rate, Survival time, Time to progression, Completion of the treatment	—

Countries

Japan

Contacts

Public ContactTakashi Nishimura

Kobe City General Hospital Division of Respiratory Medicine

t-nishi@kcgh.gr.jp078-302-4321

Outcome results

None listed

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