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

NCT01380262 | Unknown

• 1 other identifier: STLDD-1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Skin Toxicities

Keywords

Colorectal Cancer; Skin Rash; Pre-emptive treatment; Doxycycline; Anti-EGFR antibody; Cetuximab; Panitumumab

Outcome Measures

Primary Outcomes (1)

• number of patients with a severe skin toxicity

  8 weeks

Secondary Outcomes (3)

• total occurence of skin toxicities

  8 weeks

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• diagnosis of metastatic colorectal cancer,
• previously qualified to either cetuximab or panitumumab,
• written consent.

You may not qualify if:

• previous administration of cetuximab or panitumumab,
• contradictions to receive oral doxycycline.

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

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

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Exanthema

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lucjan S Wyrwicz, MD,PhD

  Maria Sklodowska-Curie National Research Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucjan S Wyrwicz, MD, PhD

CONTACT

+48225462933; lucjan@bioinfo.pl

Zbigniew I Nowecki, MD, PhD

CONTACT

+485462242; nowecki@coi.waw.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 27, 2011
• Study Start: June 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

PL (1)