A phase II study of panitumumab for refractory pateients to standard treatments with KRAS wild type advenced colorectal cancer

A phase II study of panitumumab for refractory pateients to standard treatments with KRAS wild type advenced colorectal cancer - A phase II study of panitumumab for patients with KRAS wild type colorectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000004654

Enrollment

200

Registered

2010-12-02

Start date

2010-12-01

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who have diagnosis of colorectal cancer by pathological findings are included. 2) Patients who have unresectable advanced or recurrent cancer are included. 3) Patients who have cancer with KRAS wild type are included. 4) Patients who have measurable lesions are included. 5) Patients who have past histories of treatment failures by fluoropyrimidines, irinotecan and oxaliplatin are included. 6) Patients who do not have past histories of treatment by panitumumab or cetuximab are included. 7) Patients who are over 20 year old and would expect survival over 3 months after registration are included. 8) Patients who are under 2 ECOG performance status are included. 9) Patients who have adequate bone marrow and organ functions are included. 10) Patients who have adequate heart function in 28 days before registration are included. 11) Patients who are written informed consent are included.

Exclusion criteria

Exclusion criteria: 1) Patients who have allergy for drugs are excluded. 2) Patients who have other malignancies are excluded. 3) Patients who have infections in active are excluded. 4) Patients who have past histories of bowel perforation and / or bowel obstruction in one year before registration are excluded. 5) Patients who have severe diseases are excluded. 6) Patients who have pleural effusion and / or ascites to need treatment are excluded. 7) Patients who have watery diarrhea are excluded. 8) Patients who have symptomatic brain metastasis are excluded. 9) Patients who have pregnancy are excluded. 10) Patients who receive steroid continuously are excluded. 11) Patients who have past histories of cerebral infarction, cardiac infarction and / or pulmonary infarction are excluded. 12) Patients whom physicians decide to exclude are ineligible. 13) The patient that a study responsibility physician judged to be inappropriate.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
frequency of Adverse events tumor regression rate Progression-free survival Overall survival Treatment completion rate Time to treatment failure	—

Countries

Japan

Contacts

Public ContactAyumu Goto MD. PhD.

Yokohama City University Hospital Clinical Oncology division

ayumu16g@yokohama-cu.ac.jp045-787-2800

Outcome results