Clinical trial for the prevention of skin toxicity in patients with metastatic colorectal cancer treated with panitumumab and chemotherapy
- Conditions
- Cutaneous toxicity in patients with metastatic colorectal cancerMedDRA version: 20.0Level: PTClassification code 10059516Term: Skin toxicitySystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-004413-98-ES
- Lead Sponsor
- Fundación CRIS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 34
1) Male or female of at least 18 years of age
2) Able to understand, sign and date an informed consent approved by a Research Ethics Committee with medicines (CEIm)
3) Adenocarcinoma of the colon or rectum histologically confirmed in patients with initially unresectable metastatic cancer (M1)
4) Confirmation, in the local institution, of RAS tumor not mutated before inclusion in the study
5) Patients with a treatment plan based on FOLFOX + panitumumab or FOLFIRI + panitumumab, as first-line treatment of CCRm
6) Functional status according to the ECOG (Eastern Cooperative Oncology Group) scale =2
7) Acceptable function of the bone marrow: neutrophils =1.5 × 109 / l; platelets =100 × 109 / l; hemoglobin =9 g / dl
8) Liver, renal and metabolic function as follows:
- Total bilirubin =1,5 ??times the upper limit of normal (ULN), ALT and AST <5 x ULN
- Renal function, calculated as creatinine clearance or creatinine clearance of 24 hours, =50 ml / min
- Magnesium> lower limit of normality (LIN)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1. History of metastasis or concomitant metastasis in the central nervous system (CNS)
2. History of another primary cancer, with the exception of the following: cervical cancer in situ treated with curative intent, non-melanoma skin cancer resected with curative intent or another solid primary tumor treated with curative intent with no known active cancer or treatment administered for at least 5 years before the start of treatment
3) Known hypersensitivity to tetracyclines
4) Chemotherapy or other previous systemic antineoplastic treatment to treat CCRm
5) Previous adjuvant chemotherapy for colorectal cancer completed less than 6 months before diagnosis of metastasis
6) Unresolved toxicities of a previous systemic treatment that, in the opinion of the researcher.
7) Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g., cetuximab), anti- vascular endothelial growth factor (VEGF) or treatment with small molecule EGFR inhibitors (e.g., erlotinib)
8) Prior hormonal therapy, immunotherapy or approved or experimental antibody/proteins =30 days before inclusion
9) Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia
10) History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest computed tomography (CT)
11) Treatment for systemic infection within 14 days before the start of study treatment
12) Acute or subacute intestinal occlusion and/or active inflammatory bowel disease or other bowel disease that causes chronic diarrhoea (defined as grade = 2 diarrhoea according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.03)
13) Clinically significant peripheral sensory neuropathy
14) Evidence of previous acute hypersensitivity reaction, of any grade, to any component of the treatment
15) History of Gilbert disease or known dihydropyrimidine deficiency syndrome
16) Recent gastroduodenal ulcer to be active or uncontrolled
17) Recent pulmonary embolism, deep vein thrombosis, or other significant venous event
18) Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
19) Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery
20) History of any disease that may increase the risks associated with study participation or may interfere with the interpretation of study results.
21) Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
22) Any disorder that compromises the patient’s ability to provide written informed consent and/or comply with study procedures
23) Any investigational agent within 30 days prior to inclusion
24) Pregnant or breastfeeding woman
25) Surgery (excluding diagnostic biopsy or placement of a central venous catheter) and/or radiotherapy within 28 days prior to inclusion in the study.
26) Male or female of childbearing age who do not agree with taking adequate contraceptive precautions, i.e. use contraception double barrier (e.g. diaphragm plus condoms) or abstinence during the course of the study and for 6 months after the last administration of study drug for women and 1 month for men
27) The patient is unwilling or unable to meet the requirements of the study. Psychological, geographical, familial or sociologica
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective is to describe the efficacy of toxicity, 50 or 100 mg daily, to prevent skin toxicity in patients with metastatic colorectal cancer (mCRC) treated with FOLFOX or FOLFIRI + panitumumab;Secondary Objective: - Evaluate the quality of life (QoL) of patients treated with doxycycline, 50 or 100 mg per day.<br>- Evaluate the safety and tolerability of doxycycline, 50 or 100 mg per day.;Primary end point(s): Efficacy of doxycycine to prevent skin toxicity in patients with metastatic colorectal cancer (mCRC) treated with FOLFOX or FOLFIRI + panitumumab;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment with doxycycline
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - quality of life<br>- safety and tolerability of doxycycline;Timepoint(s) of evaluation of this end point: Mean change from baseline (Visit 0) in DLQI score at week 7 (Visit 7)<br>Safety and tolerability of doxycycline will be based on all patients that received at least one dose of study treatment