---
title: Pre-emptive Low-dose Doxycycline During Anti-EGFR Treatment
nct_id: NCT01380262
overall_status: UNKNOWN
sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
study_type: OBSERVATIONAL
primary_condition: Colorectal Cancer
countries: Poland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01380262.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01380262"
ct_last_update_post_date: 2011-06-27
last_seen_at: "2026-05-12T06:14:33.313Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Pre-emptive Low-dose Doxycycline During Anti-EGFR Treatment

**Official Title:** Prospective Phase II Study on Skin Toxicity on Low-Dose Doxycycline in Metastatic Colorectal Cancer Patients During Cetuximab and Panitumumab Treatment

**NCT ID:** [NCT01380262](https://clinicaltrials.gov/study/NCT01380262)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Maria Sklodowska-Curie National Research Institute of Oncology
- **Conditions:** Colorectal Cancer, Skin Toxicities
- **Start Date:** 2010-06
- **Completion Date:** 2011-09
- **CT.gov Last Update:** 2011-06-27

## Brief Summary

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.

## Detailed Description

Patients with metastatic colorectal cancer treated with cetuximab or panitumumab usually develop the skin toxicity which can impair patients' quality of life as well as limit the treatment. We designed this trial to assess the effect of simplified protocol of pre-emptive treatment on the observed skin toxicities during cetuximab and panitumumab treatment of colorectal cancer.

The study is a cohort observational, single center study which should result in estimation of particular types of toxicities, especially occurence of more severe (grade 2 and 3) side effects and assess the tolerance of doxycyline in the prolonged administration.

The observation in the study is biweekly and is continued up to 8 weeks.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Low Dose Doxycycline** — 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

- **number of patients with a severe skin toxicity** _(time frame: 8 weeks)_

## Secondary Outcomes

- **total occurence of skin toxicities** _(time frame: 8 weeks)_
- **number of patients with delayed administration of cetuximab or panitumumab due to severe skin toxicity** _(time frame: 8 weeks)_
- **quality of life assessed with DLQI** _(time frame: 8 weeks)_

## Locations (1)

- Department of Gastrointestinal Cancer, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology, Warsaw, Masovian Voivodeship, Poland — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of gastrointestinal cancer, maria sklodowska-curie memorial cancer center, institute of oncology|warsaw|masovian voivodeship|poland` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01380262*  
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