A phase II study to evaluate the effect on the combination chemotherapy of CPT-11 and S-1 for advanced/recurrent colon cancer which combines genetic analysis on adverse events (OGSG 0405)

A phase II study to evaluate the effect on the combination chemotherapy of CPT-11 and S-1 for advanced/recurrent colon cancer which combines genetic analysis on adverse events (OGSG 0405) - OGSG 0405

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000855

Enrollment

Registered

2007-10-25

Start date

2005-11-01

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

Patients with advanced and/or recurrent colon cancer

Interventions

Day 1 Day 15 Day 21 Day 35 CPT-11 O O S-1 |.....................| **CPT-11 80mg/m2 on Day 1 and Day 15 **S-1 80-120mg/m2 between day 1 and day 21 It takes 35 days for one cours

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. colon cancer proven histologically 2. with measurable lesion 3. with/without prior chemotherapy except CPT-11 and S-1 O the last prior therapy before more than 4 weeks of registration O without any adverse events due to prior chemotherapy. 4. age: =>20 and 75=> 5. Performance Status: 0-2 (ECOG criteria) 6. more than 13 weeks of expected survival period 7. sufficient function of important organs O WBC: >= 4,000 and =< 12,000/mm3 O Neutrophyl: >= 2,000/mm3 O Platelet: >= 100,000/mm3 O hemoglobin: >= 8.0g/dl O sGOT,sGPT: 2.5 times of normal range in each institute O sT.bil.: <= 1.5 mg/dl O sCreatinin: <= upper limit of each institute O Cockcroft-Gault(Ccr): >=50ml/min O ECG: normal range 8. with ability of oral intake 9. written informed consent

Exclusion criteria

Exclusion criteria: 1. without interstitial pneumonia or pulmonary fibrosis on X-ray examination And/or clinical signs 2. Cavity fluid which needs drainage 3. with active double cancer except ca. in situ 4. with intestinal paralysis or obstruction 5. under watery diarrhea 6. with uncontrolled DM 7. with ischemic cardiac disease 8. with mental disorder which disturbs registration to this study 9. with infectious disease which needs treatment 10. patients who receive steroids treatment 11. Cardiac failure, liver dysfunction, or renal dysfunction which disturb Registration to this study 12. with brain metastasis and the symptom due to the metastasis 13. pregnant women or women who like to be pregnant 14. history of severe allergy against drug 15. doctor's dicision not to be registered to this study

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
adverse events, survival time, Relative Performance, Genomic instability	—

Countries

Japan

Contacts

Public ContactFurukawa Hiroshi

Sakai City Hospital Director

072-221-1700

Outcome results

None listed

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