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A phase 2 study, investigating prevention and treatment algorism of the skin toxicity related with Panitumumab treatment in patients with unresectable and/or metastatic CRC with KRAS wild type refractory to 5-FU containing chemotherapy

A phase 2 study, investigating prevention and treatment algorism of the skin toxicity related with Panitumumab treatment in patients with unresectable and/or metastatic CRC with KRAS wild type refractory to 5-FU containing chemotherapy - A phase 2 study, investigating prevention and treatment algorism of the skin toxicity related with Panitumumab treatment in patients with unresectable and/or metastatic CRC with KRAS wild type refractory to 5-FU containing chemotherapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005862
Enrollment
40
Registered
2011-06-28
Start date
2012-06-01
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

unresectable and/or metastatic colorectal cancer

Interventions

pre-emptive administration of minocycline hydrochloride 100mg twice per day and consistent heparinoid containing skin moisturizer, which are started at panitumumab contained chemotherapy started. And
Hydrocortisone butyrate cream 0.1% apply to face, diflupredonate ointment 0.05% apply to the other part.

Sponsors

National Cancer Center Hospital East
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who have unresectable and/or metastatic colorectal adenocarcinoma with KRAS wild type, history of progression of disease of 5-FU based chemotherapy as the first-line during the treatment or within 6 months after the last administration of the regimen, measurable lesion according to the RECIST version1.1, Eastern Cooperative Oncology Performance Status of 0-2, adequate major organ function and can comprehend and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: Patients who have central nervous system metastasis, homozygote of UGT1A1 *28 or *6, double heterozygote of UGT1A1 *28 and *6, prior anti-EGFR therapy, unresolved toxicities from prior anthi-cancer therapy, clinically significant complication, pre- or co-existing interstitial pneumoniae, do not consent to use adequate contraceptive precausions with child-bearing potential, are breast-feeding or pregnant female.

Design outcomes

Primary

MeasureTime frame
incidence rates and timing of grade two or more skin toxicity during 6 weeks from Panitumumab contained chemotherapy started.

Secondary

MeasureTime frame
response rate, disease control rate, progression free survival, overall survival, any adverce event, sebum cutaneum measurment and stratum corneum hydration measurment from Panitumumab contained chemotherapy started.

Countries

Japan

Outcome results

None listed

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