Pre-emptive Low-dose Doxycycline During Anti-EGFR Treatment

NCT ID: NCT01380262

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Skin Toxicities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Principal Investigators

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Lucjan S Wyrwicz, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Maria Sklodowska-Curie National Research Institute of Oncology

Locations

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Department of Gastrointestinal Cancer, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Lucjan S Wyrwicz, MD, PhD

Role: CONTACT

+48225462933

Zbigniew I Nowecki, MD, PhD

Role: CONTACT

+485462242

Other Identifiers

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STLDD-1

Identifier Type: -

Identifier Source: org_study_id

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