Phase I study of a combination of capecitabine plus CPT-11 (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy

Phase 1

• Conditions: Colorectal cancer

• Registration Number: JPRN-UMIN000003176
• Lead Sponsor: Osaka Medical Center for Cancer and Cardiovascular Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

1) with treatments including CPT-11 2) with active double cancers 3) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc. 4) Infectious disease 5) Diarrhea (watery stools) 6) with obstruction or disorder on digestive tract due to peritoneal metastasis 7) with ascites and/or pleural fluid 8) History of serious drug hypersensitivity 9) Undergoing anti-fungal treatment with fluorocytosine, or atazanavir sulfate. 10) Found to have fresh gastrointestinal bleeding that requires repeated transfusion. 11) With liver cirrhosis or jaundice. 12) patients undergoing treatment with a psychotropic agent or who have a mental disorder that seems to require treatment. 13) having heart disease, such as ischemic heart disease or an arrhythmia, which require treatment. 14) With diabetes that is difficult to control. 15) With central nervous system metastasis 16) Patients with UGT1A1 genotype *6/*6, *28/*28 and *6/*28 17) women pregnant, breast-feeding, or who wish pregnancy 18) Any other patient whom the physician in charge of the study judges to be unsuitable

Study & Design

• Study Type: Interventional
• Study Design: Not specified