Skin Toxicity Treatment in Metastatic Colorectal Cancer (mCRC) Patients Receiving Panitumumab + Irinotecan-based Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

January 31, 2008

Study Completion Date

September 30, 2008

Conditions
Metastatic Colorectal CancerSkin RashSkin ToxicitiesColon CancerColorectal Cancer
Interventions
BIOLOGICAL

Panitumumab

Administered by intravenous infusion

DRUG

Irinotecan

Recommended dosage regimen and administration of irinotecan was based on local standard of care, the package insert, and institutional guidelines.

DRUG

FOLFIRI

Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.

DRUG

Pre-emptive Skin Treatment

Pre-emptive skin treatment included a skin moisturizer (eg, Lubriderm), sunscreen (free of paraaminobenzoic acid (PABA), skin protection factor (SPF) 15 or higher, ultraviolet-A (UV-A), and UV-B protection), topical steroid (1% hydrocortisone cream) and oral antibiotic (doxycycline, 100 mg twice daily).

DRUG

Reactive Skin Treatment

Treatment was based on symptoms and severity and may have included an emollient (eg, Lubriderm, Vaseline), sunscreen (SPF ≥ 15), oral antibiotic (eg, doxycycline, ciprofloxacin, cefadroxil, amoxicillin/clavulanic acid), topical steroid (hydrocortisone cream), topical antibiotic (clindamycin), oral systemic steroid, topical medical treatment (eg, silver sulfadiazine, Silvadene), topical antihistamine or oral antihistamine (hydroxyzine)

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY