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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01380262
First received: June 22, 2011
Last updated: June 24, 2011
Last verified: June 2011

June 22, 2011
June 24, 2011
June 2010
September 2011   (final data collection date for primary outcome measure)
number of patients with a severe skin toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01380262 on ClinicalTrials.gov Archive Site
  • total occurence of skin toxicities [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • quality of life assessed with DLQI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    assessed as a correlation to severeness of skin toxicities
Same as current
Not Provided
Not Provided
 
Pre-emptive Low-dose Doxycycline During Anti-EGFR Treatment
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

  • Colorectal Cancer
  • Skin Toxicities
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact: Lucjan S Wyrwicz, MD, PhD +48225462933 lucjan@bioinfo.pl
Contact: Zbigniew I Nowecki, MD, PhD +485462242 nowecki@coi.waw.pl
Poland
 
NCT01380262
STLDD-1
No
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Not Provided
Principal Investigator: Lucjan S Wyrwicz, MD,PhD Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP