Phase I /II and Pharmacological Clinical Study of Combination Chemotherapy with Irinotecan(CPT-11) and Erlotinib(Tarceva) for Recurrent Lung Cancer

Phase I /II and Pharmacological Clinical Study of Combination Chemotherapy with Irinotecan(CPT-11) and Erlotinib(Tarceva) for Recurrent Lung Cancer - Phase I /II and Pharmacological Clinical Study of Combination Chemotherapy with CPT-11 and Erlotinib for Recurrent Lung Cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004639

Enrollment

Registered

2010-12-02

Start date

2010-09-01

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

recurrent non small cell lung cancer after chemotherapy

Interventions

No intrapatient dose escalation is allowed. At least three patients are enrolled at each dose level. If a DLT is observed in one of the first three patients, then three additional patients are enroll

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of non small cell lung cancer confirmed either histologically or cytologically. Recurrent case after chemotherapy.(2nd line -) ECOG performance status 0-1. CPT-11 and Erlotinib are not administerd in the previous chemotherapy. Over 18 years old. Adequate bone marrow function and organ function. Life expectancy is more than 3 months. Patient who doesn't have UGT1A1*28 homozygote. Patients who received investigation of EGFR-mutaion. Written informed consent.

Exclusion criteria

Exclusion criteria: Active infection. Severe DM. Severe heart disease, angina, myocadial infarction before 3 month. Active peptic ulcer. Concomitant malignancy. Severe neural disease. Severe comorbidity. Interstitial pneumonia in chest CT. Symptomatic brain metastasis. Severe ascites. Severe pleural effusion. Severe pericardial effusion. Impaired blodd coagulation. Pregnant, potential pregnant, or lactating. Severe drug hypersensitivity. Judged inappropriate for the trial by the doctor in charge

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
progression free survival, safety, QOL	—

Countries

Japan

Contacts

Public ContactTamio Okimoto

Shimane university hospital Clinical oncology and Respiratory medicine

0853-20-2581

Outcome results

None listed

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