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

Colorectal Cancer Clinical Trial

— STLDD-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01380262
• Other study ID #: STLDD-1
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2011
• Last updated: June 24, 2011
• Start date: June 2010
• Est. completion date: September 2011

Study information

• Verified date: June 2011
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: Lucjan S Wyrwicz, MD, PhD
• Phone: +48225462933
• Email: lucjan[@]bioinfo.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Skin Toxicities

Locations

Country	Name	City	State
Poland	Department of Gastrointestinal Cancer, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology	Warszawa	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with a severe skin toxicity		8 weeks	Yes
Secondary	total occurence of skin toxicities	analyzed for weeks: 2, 4, 6 and 8 separetly	8 weeks	Yes
Secondary	number of patients with delayed administration of cetuximab or panitumumab due to severe skin toxicity		8 weeks	Yes
Secondary	quality of life assessed with DLQI	assessed as a correlation to severeness of skin toxicities	8 weeks	No