Multicenter phase II study of FOLFIRI and bevacizumab as second-line treatment in advanced or recurrent colorectal cancer.

Multicenter phase II study of FOLFIRI and bevacizumab as second-line treatment in advanced or recurrent colorectal cancer. - PROMETEUSII

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001817

Enrollment

Registered

2009-04-01

Start date

2009-04-01

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 FOLFIRI with bevacizumab (Treatment will be continued unless the disease progression, unacceptable toxicity, or consent withdrawal.)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed adenocarcinoma of the colon or rectum. 2.Unresectable or recurrent colorectal cancer patient 3.Administered FOLFOX treatment as first-line chemotherapy 4.Diagnosed no mutation or heterozygosity by genotyping assay 5.At least one unidimensionally measurable lesion. 6.Aged >= 20 years. 7.Eastern Cooperative Oncology Group (ECOG) performance status of =<1. 8.Life expectancy at least 3 months. 9.Adequate bone marrow, heart, pulmonary, liver, and renal function. 10.Written informed consent

Exclusion criteria

Exclusion criteria: Patient with contraindication to Irinotecan, 5-FU, l-LV, or Bevacizumab.

Design outcomes

Primary

Measure	Time frame
Efficacy: Response rate	—

Countries

Japan

Contacts

Public ContactHirohiko Maeda

Yakult Honsha Co.,Ltd. Pharmaceutical Development Department, Post Marketing Development Section

hirohiko-maeda@yakult.co.jp03-5550-8962

Outcome results

None listed

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