Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01380262
Recruitment Status : Unknown
Verified June 2011 by Maria Sklodowska-Curie Institute - Oncology Center.
Recruitment status was:  Recruiting
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Maria Sklodowska-Curie Institute - Oncology Center

Tracking Information
First Submitted Date June 22, 2011
First Posted Date June 27, 2011
Last Update Posted Date June 27, 2011
Study Start Date June 2010
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2011)
number of patients with a severe skin toxicity [ Time Frame: 8 weeks ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 23, 2011)
  • total occurence of skin toxicities [ Time Frame: 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 [ Time Frame: 8 weeks ]
  • quality of life assessed with DLQI [ Time Frame: 8 weeks ]
    assessed as a correlation to severeness of skin toxicities
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pre-emptive Low-dose Doxycycline During Anti-EGFR Treatment
Official Title Prospective Phase II Study on Skin Toxicity on Low-Dose Doxycycline in Metastatic Colorectal Cancer Patients During Cetuximab and Panitumumab Treatment
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Colorectal Cancer
  • Skin Toxicities
Intervention Not Provided
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 23, 2011)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2011
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01380262
Other Study ID Numbers STLDD-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Study Sponsor Maria Sklodowska-Curie Institute - Oncology Center
Collaborators Not Provided
Investigators
Principal Investigator: Lucjan S Wyrwicz, MD,PhD Maria Sklodowska-Curie Institute - Oncology Center
PRS Account Maria Sklodowska-Curie Institute - Oncology Center
Verification Date June 2011