Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study

Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study - Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001733

Enrollment

Registered

2009-02-26

Start date

2005-07-01

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

Lung Cancer

Interventions

CDDP 60 mg/m2 day-1 (0.5-h infusion) CPT-11 30 to 60 mg/m2 day-1, 8, 15 (1.5-h infusion) HD was started immediately after completing the adminis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligibility criteria included histologically or cytologically confirmed lung cancer and renal insufficiency undergoing HD, no prior chemotherapy,life expectancy of at least 3 months, age of 20-74 years, PS of 0,1 or 2 according to the European Cooperative Oncology Group scale, the presence of measurable or evaluable disease, adequate functional indices for bone marrow leucocyte or granulocyte count >4x109/l or 2x109, PLT count100x109/l, hemoglobin concentration>9g/dl, AST ALT<100IU/l, serum bilirubin>2.0g/dl), no medical problems severe enough to prevent compliance with the protocol.

Exclusion criteria

Exclusion criteria: Patients with other concurrent malignancies, active infections, pulmonary fibrosis, uncontrolled massive pleural effusion or ascites, significant cardiovascular diseases, or symptomatic metastasis to the brain, pregnancy or breast-feeding were excluded.

Design outcomes

Primary

Measure	Time frame
To analyze pharmacokinetic parameters, and to investigate recommended dose and feasibility of combined Cx with CDDP and CPT-11 in lung cancer patients with chronic renal failure undergoing HD.	—

Secondary

Measure	Time frame
To evaluate feasibility and toxicity.	—

Countries

Japan

Contacts

Public ContactHirohisa Yoshizawa

Niigata University Medical and Dental Hospital Bioscience medical research center

hy0522@med.niigata-u.ac.jp025-227-2517

Outcome results

None listed

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