Study Complete
Sponsor ID
20050184
Skin Toxicity Treatment in metastatic colorectal cancer (mCRC) Patients receiving Panitumumab + Irinotecan-based therapySTEPP
Study Details
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.
Protocol Summary
Primary Outcome Measures
Incidence of specific grade 2 or greater skin toxicities during the 6-week skin treatment period.
Timeframe: six weeks
Secondary Outcome Measures
Incidence of grade 2 or greater skin toxicities of any type.
Timeframe: six weeks
Time to first occurrence of specific grade 2 or greater skin toxicities of interest.
Timeframe: six weeks
Most severe specific grade 2 or greater skin toxicities of interest.
Timeframe: six weeks
Time to the most severe specific grade 2 or greater skin toxicities of interest.
Timeframe: six weeks
Incidence of panitumumab dose reduction due to the specific skin toxicities of interest.
Timeframe: six weeks
Response Rate at Week 9 for the FOLFIRI and panitumumab Q2W regimen with confirmed response at Week 13 or at Week 10 for the irinotecan and panitumumab Q3W regimen with confirmed response at Week 14.
Timeframe: Weeks 9 through 14.
Best Overall Response Rate
Timeframe: unknown
Progression-free Survival
Timeframe: unknown
Rate of Disease Control at Week 9 for the FOLFIRI and panitumumab Q2W regimen with confirmed response at Week 13, at Week 10 for the irinotecan and panitumumab Q3W regimen with confirmed response at Week 14, or stable disease at Weeks 9 and 10.
Timeframe: Week 9
Time-to-treatment Failure
Timeframe: unknown
Overall Survival
Timeframe: unknown
Patient Reported Outcomes Endpoints
Timeframe: unknown
Locations
No locations found.