Colorectal Cancer Metastatic Clinical Trial
— SKINUXOfficial title:
Pre-emptive Cycline Treatment on Cetuximab-induced Skin Toxicity in Patients With Metastatic Colorectal Cancer Treated With an Intensified FOLFIRI.
Verified date | March 2020 |
Source | Institut Cancerologie de l'Ouest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 25 |
Est. completion date | October 10, 2016 |
Est. primary completion date | October 10, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | ICO Paul Papin | Angers | |
France | CHU Jean Minjoz | Besançon | |
France | CHU Morvan | Brest | |
France | Centre Hospitalier | Cholet | |
France | Centre Hospitalier Départemental Les Oudairies | La Roche Sur Yon |
Lead Sponsor | Collaborator |
---|---|
Institut Cancerologie de l'Ouest |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | reduction of Grade > or = 2 acne-like skin rash by 30% | Skin tolerance will be assessed by a dermatologist at each cycle and NCI CTCAE v4.0 will be use for grading. Skin standardized photographs will be done at every cycle and a central double blind review wil be planned. Time to first occurence of grade > or =2 skin toxicity will be assessed, and specificity. | 6 weeks of pre-emptive cycline treatment | |
Secondary | skin tolerance assessment | Skin tolerance will be assessed weekly by a dermatologist from C1 to C3, and biweekly from C4 to C6 and NCI CTCAE v4.0 will be use for grading. All grade > or = 1 skin and hair/nails toxicities will be reported. Time to most severe skin toxicity will be assessed. Quality of life questionnaires with a skin interest (DLQI) will be evaluated at baseline and at each cycle. | Until the end of Cetuximab treatment | |
Secondary | Non skin toxicities assessment | For non skin toxicities, only grade > or = 3 will be reported. | Until the end of chemotherapy treatment | |
Secondary | Efficacy Objective Response (OR) assessment | Efficacy OR (Complete Response + Partial Response) will be assessed by the investigator with usual tumoral evaluation. Tumoral evaluation will be assessed with the same exam throughout the trial. | Until the end of chemotherapy treatment | |
Secondary | Biological correlation with response and survival | Biological correlation with response and survival will be tested for KRAS, BRAF, PI3K,PTEN, epiregulin, amphiregulin, IGF1, Syndecan-1, UBE2C, EGFR polymorphism. | 3 years | |
Secondary | Time To Progression and Overall Survival | 3 years | ||
Secondary | Resectability rate | Until the end of chemotherapy treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03941080 -
Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer
|
||
Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
Completed |
NCT03647839 -
Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT05057052 -
Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis
|
Phase 2 | |
Terminated |
NCT02316496 -
Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study
|
Phase 2 | |
Completed |
NCT03251612 -
Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
Completed |
NCT02380443 -
AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT02149784 -
Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients
|
Phase 3 | |
Recruiting |
NCT01959061 -
Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases
|
Phase 4 | |
Terminated |
NCT01668680 -
Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma
|
Phase 2 | |
Recruiting |
NCT05068531 -
Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients
|
||
Not yet recruiting |
NCT04525807 -
Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory
|
||
Completed |
NCT04482608 -
The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival
|
||
Recruiting |
NCT03193710 -
The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved
|
N/A | |
Recruiting |
NCT04854213 -
PRELUDE-1 (Prospective Evaluation of Radiotherapy-induced Biologic Effects in Colorectal Cancer Oligometastatic Patients With LUng-limited Disease: Evolution of Cancer Genetics and Regulatory Immune Cells)
|
N/A | |
Suspended |
NCT04108481 -
Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03142516 -
FOLFIRI + Panitumumab First-line Treatment in Elderly Patients With Unresectable Metastatic Colorectal Cancer, RAS/BRAF Wild-type and Good Performance Status
|
Phase 2 | |
Completed |
NCT03144804 -
A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01910610 -
Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer
|
Phase 3 | |
Recruiting |
NCT05759728 -
A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer
|
Phase 1/Phase 2 |