Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition
Colorectal Cancer
Skin Toxicities

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Phase II Study on Skin Toxicity on Low-Dose Doxycycline in Metastatic Colorectal Cancer Patients During Cetuximab and Panitumumab Treatment

Resource links provided by NLM:


Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:

Primary Outcome Measures:
  • number of patients with a severe skin toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: June 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380262

Contacts
Contact: Lucjan S Wyrwicz, MD, PhD +48225462933 lucjan@bioinfo.pl
Contact: Zbigniew I Nowecki, MD, PhD +485462242 nowecki@coi.waw.pl

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

No publications provided

Responsible Party: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier: NCT01380262     History of Changes
Other Study ID Numbers: STLDD-1
Study First Received: June 22, 2011
Last Updated: June 24, 2011
Health Authority: Poland: Ethics Committee

Keywords provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:
Colorectal Cancer
Skin Rash
Pre-emptive treatment
Doxycycline
Anti-EGFR antibody
Cetuximab
Panitumumab

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Cetuximab
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014