Colorectal CancerSTLDD-1NCT01380262
Pre-emptive Low-dose Doxycycline During Anti-EGFR Treatment
An observational study of Colorectal Cancer and Skin Toxicities, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer, Skin Toxicities
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2010to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- diagnosis of metastatic colorectal cancer,
- previously qualified to either cetuximab or panitumumab,
- written consent.
Who cannot join
- previous administration of cetuximab or panitumumab,
- contradictions to receive oral doxycycline.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Gastrointestinal Cancer, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Warsaw, Masovian Voivodeship, 02-781
Lucjan S. Wyrwicz, MD, PhD
Agnieszka Byszek, MPharm
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer, Skin Toxicities
- Keywords
- Colorectal Cancer, Skin Rash, Pre-emptive treatment, Doxycycline, Anti-EGFR antibody, Cetuximab, Panitumumab
- Medical subject headings
- Colorectal Neoplasms, Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
number of patients with a severe skin toxicity
Measured: 8 weeks
Secondary outcomes (3)
total occurence of skin toxicities
analyzed for weeks: 2, 4, 6 and 8 separetly
Measured: 8 weeks
number of patients with delayed administration of cetuximab or panitumumab due to severe skin toxicity
Measured: 8 weeks
quality of life assessed with DLQI
assessed as a correlation to severeness of skin toxicities
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Investigators
- Lucjan S Wyrwicz, MD,PhD, Principal investigator, Maria Sklodowska-Curie National Research Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380262
- Sponsor's protocol ID
- STLDD-1
- Acronym
- STLDD-1
- Status last verified
- Jun 2011
- First submitted
- 22 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Study on Skin Toxicity on Low-Dose Doxycycline in Metastatic Colorectal Cancer Patients During Cetuximab and Panitumumab Treatment
- ClinicalTrials.gov ID
- NCT01380262
- Acronym / sponsor ID
- STLDD-1 / STLDD-1
- Conditions
- Colorectal Cancer, Skin Toxicities
- Keywords
- Colorectal Cancer, Skin Rash, Pre-emptive treatment, Doxycycline, Anti-EGFR antibody, Cetuximab, Panitumumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- diagnosis of metastatic colorectal cancer,
- previously qualified to either cetuximab or panitumumab,
- written consent.
Key exclusion criteria (2 listed)
- previous administration of cetuximab or panitumumab,
- contradictions to receive oral doxycycline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of patients with a severe skin toxicity
Time frame: 8 weeks
3 secondary outcomes
total occurence of skin toxicities
Time frame: 8 weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucjan S Wyrwicz, MD,PhD principal investigator
Maria Sklodowska-Curie National Research Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Skin Toxicities, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucjan S Wyrwicz, MD, PhD (+48225462933, lucjan@bioinfo.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with a severe skin toxicity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.