Pre-emptive Cycline Treatment on Cetuximab Induced Skin Toxicity in Colorectal Cancer

• Status: Terminated
• Trial end date: 2016-10-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ICO Paul Papin; Institut Cancerologie de l'Ouest
• Treatments: Cetuximab; Doxycycline

Criteria

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