Trial record 17 of 37 for:
Open Studies | "Vitamin K"
Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Universitätsmedizin Mannheim.
Recruitment status was Recruiting
Information provided by:
First received: April 21, 2011
Last updated: April 28, 2011
Last verified: April 2011
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.
Metastatic Colorectal Cancer
Device: Reconval K1 Cream
Device: Reconval Cream
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Double Blind Placebo Controlled Randomized Phase II Study Evaluating the Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream in First Line mCRC Patients Treated With Erbitux and FOLFIRI.
Primary Outcome Measures:
- Occurrence of acne-like skin rash grade ≥ 2 (according to the CTCAE version 4.02) during the 8 weeks of skin treatment. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
Experimental: Metastatic colorectal cancer, Doxycycline, Vitamin K1 Cream
Device: Reconval K1 Cream
Placebo Comparator: Metastatic colorectal cancer, Doxycycline, Cream
Device: Reconval Cream
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)).
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345526
|Unversity Hospital Mannheim
|Mannheim, Germany, 68167 |
|Contact: Ralf Hofheinz, Prof. +49 621 383 2855 Ralf.Hofheinz@umm.de |
|Institute of Oncology Ljubljana
|Ljubljana, Slovenia, 1000 |
|Contact: Janja Ocvirk, Prof. + 386 15879220 email@example.com |
||Ralf Hofheinz, Prof.
No publications provided
||Ralf Hofheinz, University Hospital Mannheim
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 21, 2011
||April 28, 2011
||Germany: Federal Institute for Drugs and Medical Devices
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 16, 2014
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Physiological Effects of Drugs
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action