Feasibility reevaluation of 75mg/m2 dose of docetaxel in Japanese patient with previously treated non-small cell lung cancer

Feasibility reevaluation of 75mg/m2 dose of docetaxel in Japanese patient with previously treated non-small cell lung cancer - Feasibility reevaluation of 75mg/m2 dose of docetaxel

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003021

Enrollment

Registered

2010-01-13

Start date

2010-01-01

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

Docetaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven non-small-cell lung cancer. 2) Patient who has measurable lesion by RECIST. 3) Patients who have previously treated one or two regimen including at least one platinum-based regimen. 4) Interval from previous treatment, of following, at enrollment; (a) Chemotherapy: more than 4 weeks after the last chemotherapy. (b) Radiation: more than 4 weeks after the thoracic irradiation or more than 2weeks after the last irradiation to the other organs. 5) Aged range from 20 to 74 years. 6) ECOG performance status: 0-1 7) No history of receiving chemotherapy against other concomitant malignancy. 8) Adequate organ functions; (a) WBC >= 4,000/mm3 and Netrophile >= 2,000/mm3 (b) Hb >= 9.0 g/dL (c) Plt >= 100,000/mm3 (d) T. Bil <= 1.5 g/dL (e) AST and ALT, x 2.5 of upper limit of normal or less (f) Serum creatinine <= 1.5 mg/dL (g) PaO2 >= 70 torr (at room) 9) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patient with prior chemotherapy, consisting of docetaxel. 2) Patients with symptomatic brain metastasis. 3) Patients with massive pleural or pericardial effusion. 4) Patients with active concomitant malignancy. 5) Patients with pregnancy or lactation. 6) Patients with other clinically significant complications. (a) uncontrollable cardiovascular disease. (b) Active lung disease such as interstitial pneumonia, idiopathic pulmonary fibrosis. (c) Active severe infections. (d) History of active psychological disease. (e) Inappropriate patients for this study judged by the physicians. 7) Patients with steroid treatment. 8) Patients with >= grade 2 of peripheral neuropathy. 9) Patients who had a history of severe drug allergy.

Design outcomes

Primary

Measure	Time frame
The frequency of DLT and tolerability.	—

Countries

Japan

Contacts

Public ContactKazuhiko Yamada

Kurume University School of Medicine Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine

Outcome results

None listed

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