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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 (STEPP)
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.
Details
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 95 |
| Start date | 2006-04 |
| Completion | 2008-09 |
Conditions
- Metastatic Colorectal Cancer
- Skin Rash
- Skin Toxicities
- Colon Cancer
- Colorectal Cancer
Interventions
- Panitumumab
- Irinotecan
- FOLFIRI
- Pre-emptive Skin Treatment
- Reactive Skin Treatment
Primary outcomes
- Percentage of Participants With Specific Grade 2 or Higher Skin Toxicities During the 6-week Skin Treatment Period — 6 weeks
Skin toxicities were assessed by the study clinician and graded according to the modified Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.