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

Amgen

Status and phase: Completed; Phase 2

Conditions: Metastatic Colorectal Cancer; Colon Cancer; Skin Rash; Skin Toxicities; Colorectal Cancer

Treatments: Drug: Pre-emptive Skin Treatment; Drug: FOLFIRI; Drug: Reactive Skin Treatment; Drug: Irinotecan; Biological: Panitumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00332163

20050184

Details and patient eligibility

About

A comparison of prophylactic treatment with reactive treatment for skin toxicity observed in patients with metastatic colorectal cancer (mCRC) who are receiving second-line irinotecan-based chemotherapy concomitantly with panitumumab.

Enrollment: 95 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with unresectable metastatic adenocarcinoma of the colon or rectum that cannot, in the opinion of the investigator, be cured by surgical resection at the time of randomization;
• Patients who have failed first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with or without bevacizumab for mCRC.

Exclusion criteria

• Prior irinotecan use for the treatment of mCRC.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

Pre-emptive Skin Treatment

Experimental group

Description:

Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.

Treatment:

Biological: Panitumumab

Drug: Irinotecan

Drug: Pre-emptive Skin Treatment

Drug: FOLFIRI

Reactive Skin Treatment

Experimental group

Description:

Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.

Treatment:

Biological: Panitumumab

Drug: Reactive Skin Treatment

Drug: Irinotecan

Drug: FOLFIRI