Phase I Study of Irinotecan and Erlotinib in Patients with Erlotinib Failure for EGFR Mutations Non-Small Cell Lung Cancer

Phase I Study of Irinotecan and Erlotinib in Patients with Erlotinib Failure for EGFR Mutations Non-Small Cell Lung Cancer - Phase I Study of Irinotecan and Erlotinib in Patients with Erlotinib Failure for EGFR Mutations Non-Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005873

Enrollment

Registered

2011-06-29

Start date

2011-06-01

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

Irinotecan and Erlotinib therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Stage IIIB/IV non-small cell lung cancer proven by histology and post-operative recurrent disease. 2)Two prior systemic chemotherapy regimens. 3)Erlotinib treatment is done for three weeks or more, interstitial pneumonia is not admitted, and effect of SD or more. 4)Possible cases with oral administration. 5)No prior treatment with irinotecan. 6)Diagnosed no mutation or heterozygosity of UGT1A1*6/*28 7)EGFR mutations in the tumor specimens. 8)Measurable lesion by RECIST. 9)ECOG Performance status(PS) of 0-1. 10)A life expectancy of more than 3 months. 11)No severe impairment of major organs (bone marrow, heart, lungs, liver, kidneys, etc.), laboratory data within 14 days WBC >=3,000/mm3 and <=12,000mm3 neutrophil >=1,500/mm3 platelet >=100,000/mm3 hemoglobin >=8.0g/dL AST and ALT <=2.5 ULN T-Bil <=1.5 ULN Cr <=ULN SpO2(Room air)>=92% 12)Written informed consent.

Exclusion criteria

Exclusion criteria: 1)Diagnosed mutation or heterozygosity of UGT1A1*6/*28. 2)Serious drug allergy. 3)Interstitial pneumonia documented obviously in chest X ray. 4)massive pleural or pericardial effusion ,or ascites. 5)active severe infections. 6)Active synchronous malignancies. 7)Pregnant or beeast-feeding woman or patient who doesn't agree to contraception. 8)Serious psychological disease. 9)brain metastasis. 10)Clinically significant heart disease (myocardial infarction within 12 months, etc.). 11)Uncontrolled diabetes mellitus. 12)Watery diarrhea. 13)Ileus or bowel obstruction. 14)bleeding that requires medication or transfusion. 15)Clinically significant complication. 16)Investigator's judgement.

Design outcomes

Primary

Measure	Time frame
To determine the recommend dose of irinotecan and erlotinib therapy	—

Secondary

Measure	Time frame
1. safety 2. response rate 3. disease control rate	—

Countries

Japan

Contacts

Public Contactkazuhito Funai

Hamamatsu University School of Medicine First Department of Surgery

kfunai@hama-med.ac.jp053-435-2276

Outcome results

None listed

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