Clinical trial · Interventional

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

A Phase 2, Open-label, Randomized Clinical Trial of Skin Toxicity Treatment in Subjects Receiving Second-line FOLFIRI or Irinotecan Only Chemotherapy Concomitantly With Panitumumab

NCT00332163CI-TRIAL-00021056STEPPcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Colon Cancer	Malignant Colon Neoplasm	CURATED_EXACT	0.92
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Metastatic Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Skin Rash	—	UNRESOLVED	—
Skin Toxicities	—	UNRESOLVED	—

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
FOLFIRI	Drug	FOLFIRI Regimen	ALIAS
Irinotecan	Drug	Irinotecan	ALIAS
Panitumumab	Biological	Panitumumab	ALIAS
Pre-emptive Skin Treatment	Drug	—	UNRESOLVED
Reactive Skin Treatment	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Pre-emptive Skin Treatment
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.
interventionNames
1. Biological: Panitumumab
2. Drug: Irinotecan
3. Drug: FOLFIRI
4. Drug: Pre-emptive Skin Treatment
type
EXPERIMENTAL
label
Reactive Skin Treatment
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 90 Years

Show eligibility criteria text

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.

References

Publications (3)

BACKGROUNDLacouture ME, Mitchell EP, Piperdi B, Pillai MV, Shearer H, Iannotti N, Xu F, Yassine M. Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-Emptive Skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin Oncol. 2010 Mar 10;28(8):1351-7. doi: 10.1200/JCO.2008.21.7828. Epub 2010 Feb 8. PMID 20142600
DERIVEDWeeraratne D, Chen A, Pennucci JJ, Wu CY, Zhang K, Wright J, Perez-Ruixo JJ, Yang BB, Kaliyaperumal A, Gupta S, Swanson SJ, Chirmule N, Starcevic M. Immunogenicity of panitumumab in combination chemotherapy clinical trials. BMC Clin Pharmacol. 2011 Nov 9;11:17. doi: 10.1186/1472-6904-11-17. PMID 22070868
DERIVEDMitchell EP, Piperdi B, Lacouture ME, Shearer H, Iannotti N, Pillai MV, Xu F, Yassine M. The efficacy and safety of panitumumab administered concomitantly with FOLFIRI or Irinotecan in second-line therapy for metastatic colorectal cancer: the secondary analysis from STEPP (Skin Toxicity Evaluation Protocol With Panitumumab) by KRAS status. Clin Colorectal Cancer. 2011 Dec;10(4):333-9. doi: 10.1016/j.clcc.2011.06.004. Epub 2011 Oct 14. PMID 22000810