STLDD-1: Pre-emptive Low-dose Doxycycline During Anti-EGFR Treatment

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology (Other)

Overall Status

Unknown status

CT.gov ID

NCT01380262

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Skin Toxicities

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2010

Anticipated Primary Completion Date :

Sep 1, 2011

Anticipated Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

number of patients with a severe skin toxicity [8 weeks]

Secondary Outcome Measures

total occurence of skin toxicities [8 weeks]
analyzed for weeks: 2, 4, 6 and 8 separetly
number of patients with delayed administration of cetuximab or panitumumab due to severe skin toxicity [8 weeks]
quality of life assessed with DLQI [8 weeks]
assessed as a correlation to severeness of skin toxicities