Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream
Phase 2
Completed
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Device: Reconval K1 CreamDevice: Reconval Cream
- Registration Number
- NCT01345526
- Lead Sponsor
- Universitätsmedizin Mannheim
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metastatic colorectal cancer, Doxycycline, Vitamin K1 Cream Reconval K1 Cream - Metastatic colorectal cancer, Doxycycline, Cream Reconval Cream -
- Primary Outcome Measures
Name Time Method PFS rate, toxicity, compliance Week 8 Occurrence of acne-like skin rash grade ≥ 2 (according to the CTCAE) version 4.02) during the 8 weeks of skin treatment. Week 8
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Institute of Oncology Ljubljana
🇸🇮Ljubljana, Slovenia
Unversity Hospital Mannheim
🇩🇪Mannheim, Germany