IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Pre-emptive Low-dose Doxycycline During Anti-EGFR Treatment (STLDD-1)
Recruitment status was: Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- number of patients with a severe skin toxicity [ Time Frame: 8 weeks ]
- 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
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01380262
| Contact: Lucjan S Wyrwicz, MD, PhD | +48225462933 | lucjan@bioinfo.pl | |
| Contact: Zbigniew I Nowecki, MD, PhD | +485462242 | nowecki@coi.waw.pl |
| 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 | |
| Principal Investigator: | Lucjan S Wyrwicz, MD,PhD | Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology |
More Information
| 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 |
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 Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Cetuximab Doxycycline Antineoplastic Agents Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on June 26, 2017