Genetic Polymorphism oriented Phase II Study of Irinotecan and Doxifluridine for Unresectable or Recurrent Colorectal Cancer

Genetic Polymorphism oriented Phase II Study of Irinotecan and Doxifluridine for Unresectable or Recurrent Colorectal Cancer - Genetic Polymorphism oriented Phase II Study of Irinotecan and Doxifluridine for advanced Colorectal Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005011

Enrollment

Registered

2011-02-03

Start date

2005-10-01

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

colorectal cancer

Interventions

Irinotecan was infused 150 mg/m2 for pts with *1/*1 genotype and 70 mg/m2 for *1/*28. Irinotecan was infused 150 mg/m2 for pts with *1/*1 genotype and 70 mg/m2 for *1/*28.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients were eligible for this study if they met the following criteria: proven unresectable or recurrent colorectal cancer; age between 20 and 80 years; no radiotherapy or chemotherapy prior to the study; Eastern Cooperative Oncology Group performance status of 0 to 1;predicted life expectancy of at least 3 months; adequate baseline organ functions, defined as a leukocyte count of at least 4,000/uL, neutrophil count of at least 2,000/uL, platelet count of at least 100,000/uL, hemoglobin of at least 9.0 g/dL, AST and ALT of 3 times or less the upper limit of the institutional reference range; total bilirubin below 1.5 mg/dL, and serum creatinine below 1.5 mg/dL.

Exclusion criteria

Exclusion criteria: Patients were ineligible if they had any of the following conditions: serious infectious disease or other severe complications (e.g., pulmonary fibrosis/interstitial pneumonia, uncontrollable diabetes); watery diarrhea, paralytic ileus, or intestinal obstruction; massive pleural effusion or ascitic fluid; symptomatic brain metastases; active concurrent malignancies; pregnancy or lactation, or desire for pregnancy; a history of drug allergy; and prior treatment with irinotecan.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Countries

Japan

Contacts

Public ContactShoichi Hazama

YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE Department of Digestive Surgery and Surgical Oncology

hazama@yamaguchi-u.ac.jp

Outcome results

None listed

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