Clinical trial · Observational
Pre-emptive Low-dose Doxycycline During Anti-EGFR Treatment
Prospective Phase II Study on Skin Toxicity on Low-Dose Doxycycline in Metastatic Colorectal Cancer Patients During Cetuximab and Panitumumab Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Up to 60% of patients with metastatic colorectal cancer can be treated with one of monoclonal antibodies targeted against epidermal growth factor receptor (EGFR). This treatment is associated with a specific spectrum of toxicity: acne-like rash from limited up to erythema, often with severe pruritus, sometimes combined with other types of skin toxicities (hair and nail changes). Previously in STEPP study investigators shown that pre-emptive treatment with oral doxycycline (200 mg daily), topical steroids and sun blockers reduces the number of more severe skin side effects of panitumumab. The study is designed to described the profile of skin toxicity of EGFR blocking drugs combined with low-dose doxycycline (100 mg daily) used in the pre-emptive manner.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Skin Toxicities | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Low Dose Doxycycline
- description
- Patients with metastatic colorectal cancer, qualified to either cetuximab or panitumumab based systemic treatment (either monotherapy or with chemotherapy) receiving a 100 mg of doxycycline daily
Primary outcomes (1)
- measure
- number of patients with a severe skin toxicity
- timeFrame
- 8 weeks
Secondary outcomes (3)
- measure
- total occurence of skin toxicities
- timeFrame
- 8 weeks
- description
- analyzed for weeks: 2, 4, 6 and 8 separetly
- measure
- number of patients with delayed administration of cetuximab or panitumumab due to severe skin toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis of metastatic colorectal cancer, * previously qualified to either cetuximab or panitumumab, * written consent. Exclusion Criteria: * previous administration of cetuximab or panitumumab, * contradictions to receive oral doxycycline.
References
Publications (0)
Data not yet available