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

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

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-781
      • Recruiting
      • Department of Gastrointestinal Cancer, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
      • Principal Investigator: Lucjan S. Wyrwicz, MD, PhD
      • Sub-Investigator: Agnieszka Byszek, MPharm
      • Sub-Investigator: Zbigniew I Nowecki, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of patients with a severe skin toxicity	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total occurence of skin toxicities	analyzed for weeks: 2, 4, 6 and 8 separetly	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	assessed as a correlation to severeness of skin toxicities	8 weeks

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Investigators: Principal Investigator: Lucjan S Wyrwicz, MD,PhD, Maria Sklodowska-Curie National Research Institute of Oncology

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): September 1, 2011
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: June 23, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): June 27, 2011
• Last Update Submitted That Met QC Criteria: June 24, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Cetuximab; Panitumumab; Doxycycline; Skin Rash; Pre-emptive treatment; Anti-EGFR antibody
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: STLDD-1