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Phase I study of XELOXIRI(CPT-11,L-OHP, capecitabine) with Bevacizumab in patients with unresectable advanced/metastatic colorectal cancer

Phase I study of XELOXIRI(CPT-11,L-OHP, capecitabine) with Bevacizumab in patients with unresectable advanced/metastatic colorectal cancer - Phase I study ofXELOXIRI with Bevacizumab for metastatic coloectal cancer

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005440
Enrollment
24
Registered
2011-04-14
Start date
2010-04-01
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

Patients receive infusional CPT-11,L-OHP, bevacizumab, and oral capecitabine every 21 days.

Sponsors

Sapporo Medical University School of Medicine Dept. of Internal Medicine(4)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically confirmed colorectal cancer. 2)Clinically proven unresectable advanced/ metastatic colorectal cancer 3) 20 to 74 years of age 4) ECOG performance status 0-1 5) Presence of measurable lesion 6) No previous history of chemotherapy or radiotherapy for unresectable advanced/ metastatic colorectal cancer 8) Adequate organ functions 9) Estimated life expectancy 3 months 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1)Prior severe drug allergy. 2) Synchronous and/or metachronous multiple cancers. 3) Prior chemotherapy with CPT-11,L-OHP, capecitabeine or Bevacizumab containing regimen. 4)Surgical procedure within 28 days prior to enrollment. 5) Severe comorbidity - Severe pulmonary dysfunction - Uncontrolled DM - Uncontrolled HT - Severe cardiovascular disease - Cirrhosis and liver failure - Renal failure 6) Sensory neuropathy 7) Severe diarrhea 8) Active infection 9) Symptomatic pleural effusion or ascites 10)Contraindications to CPT-11, L-OHP, capecitabeine or Bevacizumab 11) Concerning pregnancy 12) The investigator considers not suitable for the study.

Design outcomes

Primary

MeasureTime frame
Safety

Secondary

MeasureTime frame
Response rate

Countries

Japan

Contacts

Public ContactYasushi Sato

Sapporo Medical University School of Medicine Dept. of Internal Medicine(4)

yasushis@sapmed.ac.jp011-611-2111

Outcome results

None listed

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