Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream

Universitätsmedizin Mannheim

Status and phase

Completed

Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Device: Reconval K1 Cream

Device: Reconval Cream

Study type

Interventional

Funder types

Other

Identifiers

NCT01345526

E-VITA

Details and patient eligibility

About

The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving first line cetuximab treatment.

Full description

Enrollment

124 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent must be given
Patient ≥ 18 years
Histologically proven and measurable metastatic adenocarcinoma of the colon or rectum (according to modified RECIST criteria v.1.1)
Patients eligible for Erbitux and FOLFIRI treatment K-Ras wild type tumour
Metastatic disease
Life expectancy of at least 12 weeks
WHO performance status of 0 or 1
Effective contraception for both male and female patients if the risk of conception exists
Adequate organ function
Adequate bone marrow, hepatic and renal function (Hemoglobin > 10.0 g/dL, platelet count > 100 x 109/L, absolute neutrophil count > 1.5 x 109/L; ALAT, ASAT < 2.5 x ULN (upper limit of normal range) or < 5x ULN in case of liver metastasis; Alkaline phosphatase < 2.5 x ULN; Total bilirubin < 1.5 x ULN; Creatinine clearance > 50 mL/min (calculated according to Cockcroft and Gault formula)).

Exclusion criteria

Prior treatment for metastatic disease (adjuvant therapy with 5-FU/oxaliplatin based regimens) allowed if stopped 6 months prior to registration on study
Prior treatment with EGFR inhibitor
Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
Administration of any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drugs
Concurrent chronic systemic immune therapy, chemotherapy, radiation therapy or hormone therapy not indicated in the study protocol
Any active dermatological condition > grade 1 at baseline possibly interfering with or influencing the results or conduct of the present study
Brain metastasis (known or suspected)
Significant impairment of intestinal resorption (e.g. chronic diarrhea, inflammatory bowel disease)
Any other uncontrolled concomitant illness, including serious uncontrolled intercurrent infection
Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
Known allergy or any other adverse reaction to any of the study drugs or to any related compound.
Any organ allograft requiring immunosuppressive therapy.
Pregnancy (absence to be confirmed by serum/urine beta human chorion gonadotrophin (HCG)) or breast-feeding.
Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix surgically cured or adequately treated.
Known drug abuse / alcohol abuse
Legal incapacity or limited legal capacity
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and followup schedule; those conditions should be discussed with the patient before registration in the trial.
Medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or meaningfully sign informed consent.
Known M. Meulengracht (Gilbert´s disease) or DPD-insufficiency
Known coagulation disorders
Ongoing or planned treatment with coumarin derivates