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 Memorial Cancer Center, Institute of Oncology.
Recruitment status was: Recruiting
First Posted
: June 27, 2011
Last Update Posted
: June 27, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease |
|---|
| Colorectal Cancer Skin Toxicities |
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 |
| Estimated Enrollment : | 40 participants |
| 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 |
| Study Start Date : | June 2010 |
| Estimated Primary Completion Date : | September 2011 |
| Estimated Study Completion Date : | September 2011 |
| Group/Cohort |
|---|
|
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
|
- 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
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, Learn About Clinical Studies.
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology |
| ClinicalTrials.gov Identifier: | NCT01380262 History of Changes |
| Other Study ID Numbers: |
STLDD-1 |
| First Posted: | June 27, 2011 Key Record Dates |
| Last Update Posted: | June 27, 2011 |
| Last Verified: | June 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 |