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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Colorectal Cancer Skin Rash Skin Toxicities Colon Cancer Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pre-emptive Skin Treatment

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.

Group Type EXPERIMENTAL

Panitumumab

Intervention Type BIOLOGICAL

Administered by intravenous infusion

Irinotecan

Intervention Type DRUG

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

FOLFIRI

Intervention Type DRUG

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.

Pre-emptive Skin Treatment

Intervention Type DRUG

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).

Reactive Skin Treatment

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.

Group Type EXPERIMENTAL

Panitumumab

Intervention Type BIOLOGICAL

Administered by intravenous infusion

Irinotecan

Intervention Type DRUG

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

FOLFIRI

Intervention Type DRUG

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.

Reactive Skin Treatment

Intervention Type DRUG

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)

Interventions

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Panitumumab

Administered by intravenous infusion

Intervention Type BIOLOGICAL

Irinotecan

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

Intervention Type 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.

Intervention Type 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).

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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Vectibix

Eligibility Criteria

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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.