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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01380262
Other study ID # STLDD-1
Secondary ID
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


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
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