Clinical trial · Interventional
Pre-emptive Cycline Treatment on Cetuximab Induced Skin Toxicity in Colorectal Cancer
Pre-emptive Cycline Treatment on Cetuximab-induced Skin Toxicity in Patients With Metastatic Colorectal Cancer Treated With an Intensified FOLFIRI.
NCT01317433CI-TRIAL-00044237SKINUXterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study stopped due to a lack of recruitment
Summary
Brief summary (as posted)
The aim of this study is to test the role of cycline in the prevention of acne-like skin rash in metastatic colorectal patients treated with Cetuximab and intensified FOLFIRI.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Metastatic | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Skin Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Doxycycline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Intensified FOLFIRI plus Cetuximab + Doxycycline 100 mg daily per os to start 7 days before Cetuximab for 6 weeks + skin moisturizers (Dexeryl), sun protection.
- interventionNames
- Drug: Doxycycline
- Drug: Cetuximab
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Intensified FOLFIRI plus Cetuximab + skin moisturizers (Dexeryl), sun protection.
- interventionNames
- Drug: Cetuximab
Primary outcomes (1)
- measure
- reduction of Grade > or = 2 acne-like skin rash by 30%
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced or metastatic colorectal cancer, histologically confirmed, first or second metastatic line * K-RAS wild-type * Adjuvant prior chemotherapy allowed provided that all toxicities are grade \< or = 1 (excepted alopecia and neuropathy) * Age between 18 and 80 years * WHO Performance Status \< or = 2 * Complete initial assessment before first treatment administration for imaging and pharmacogenetic, within 15 days for biology, and within 7 days for clinical examination. * Haematologic and hepatic parameters : neutrophils \> or = 1500 /mm3, platelets \> or = 100000/mm3, Total bilirubin \< or 2 x ULN, AST and ALT \< or = 3 x ULN, APL \< or = 5 x ULN * Absence of total dihydropyrimidine dehydrogenase deficiency * Patient able to comply with study requirements * Signed written informed consent Exclusion Criteria: * History or presence of an other cancer, excepted cutaneous cancer (basocellular carcinoma), in situ cancer of the cervix or breast cancer curatively treated * Any other concomitant anti-cancer therapy * Prior anti EGFR therapy, anti angiogenic therapy is allowed * Prior cyclines hypersensitivity * Treatment with cyclines within 7 days before randomization * Presence of a rash at randomization time * Symptomatic or uncontrolled ventral nervous system metastases * Total dihydropyrimidine dehydrogenase deficiency * No recovery of any toxicity Grade \< or = 1 related to a past anticancerous treatment excepted for alopecia and neuropathy * Active inflammatory bowel disease or other bowel * Significant serious pathology or any unstable medical condition (cardiac pathology uncontrolled, myocardial infarction within 6 months before enrollment, systemic active uncontrolled infection) * atropine contra-indication * any investigational agent without marketing authorization within 4 weeks before enrollment * Patient who is pregnant or breast feeding * Woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the study
References
Publications (0)
Data not yet available
No reference posted for this study.