Phase 2
N=95
Skin Toxicity Treatment in Metastatic Colorectal Cancer (mCRC) Patients Receiving Panitumumab + Irinotecan-based Therapy
Metastatic Colorectal Cancer · Skin Rash · Skin Toxicities · Colon Cancer · Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00332163 ↗Enrolled (actual)
95
Serious AEs
37.9%
Results posted
Feb 2016
Primary outcome: Primary: Percentage of Participants With Specific Grade 2 or Higher Skin Toxicities During the 6-week Skin Treatment Period — 29; 62 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Panitumumab (Biological); Irinotecan (Drug); FOLFIRI (Drug); Pre-emptive Skin Treatment (Drug); Reactive Skin Treatment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Specific Grade 2 or Higher Skin Toxicities During the 6-week Skin Treatment Period |
29; 62 | — |
| SECONDARY Percentage of Participants With Any Grade 2 or Higher Skin Toxicity of Any Type During the 6-week Skin Treatment Period |
40; 62 | — |
| SECONDARY Time to First Occurrence of Specific Grade 2 or Higher Skin Toxicities of Interest |
NA; 2.1 | — |
| SECONDARY Most Severe Specific Grade 2 or Higher Skin Toxicities of Interest |
23; 40; 6; 21; 0; 0 | — |
| SECONDARY Time to First Most Severe Specific Grade 2 or Higher Skin Toxicities of Interest |
NA; 2.7 | — |
| SECONDARY Percentage of Participants With Panitumumab Dose Reductions Due to the Specific Skin Toxicities of Interest |
6; 11 | — |
| SECONDARY Response Rate at First Scheduled Assessment |
6; 6 | — |
| SECONDARY Best Overall Response Rate |
15; 11 | — |
| SECONDARY Rate of Disease Control at First Scheduled Assessment |
63; 64 | — |
| SECONDARY Time to Treatment Failure |
3.1; 4.2 | — |
| SECONDARY Time to Progression |
4.9; 4.1 | — |
| SECONDARY Overall Survival |
11.2; 13.6 | — |
| SECONDARY Progression-free Survival |
4.7; 4.1 | — |
| SECONDARY Change From Baseline in Overall Dermatologic Quality of Life Index (DLQI) Score |
0.3; 0.1; 0.7; 1.6; 1.3; 4.2 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00332163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.