Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study

Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study - Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000084

Enrollment

Registered

2005-09-01

Start date

2001-10-01

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 carcinoma

Interventions

Chemotherapy CPT-11 (60 mg/m2, weekly) CDDP (25 mg/mg2, weekly) at leaset 6 courses

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically/cytologically proven non-small-cell lung cancer 2) Prior chemotherapy of single regimen chemotherapy 3) Resistant to first line chemotherapy or relapsed after the chemotherapy 4) PS (ECOG); 0 - 2 5) Age ranging from 15 to 74 6) Preserved organ functions as a) WBC >= 3,000/mm3, neutrophile >= 2,000/mm3, Hb >= 9.0 g/dl, Plt >= 100,000/mm3 b) T. Bil = 40 ml/min d) PaO2 >= 70 torr 7) Measurable lesions by RECIST 8) Life expectancy for more than 8 weeks 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Prior chemotherapy including irinotecan 2) Prior chemotherapy by 2 or more chemotherapeutic regimens 3) Prior resection 4) Requirement of thoracic irradiation 5) Any contraindication for irinotecan, such as interstitial pneumonitis 6) Pleural effusion/ascites requiring treatment 7) Pericardial effusion 8) Serious concomitant medical conditions, including uncontrolled diabetes mellitus, angina pectoris, myocardial infarction within 3 months, and others 9) Brain metastasis requiring treatment 10) Concomitant malignancy 11) History of serious drug allergy 12) Pregnancy, potential pregnancy, or breast feeding 13) Others

Design outcomes

Primary

Measure	Time frame
Response rate (6 weeks interval for confirming SD)	—

Secondary

Measure	Time frame
Toxicity Survival	—

Countries

Japan

Contacts

Public ContactTakiguchi, Yuichi

Chiba University Department of Respirology (B2)

takiguchi@faculty.chiba-u.jp043-226-2577

Outcome results

None listed

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