Trial record 17 of 40 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 firstname.lastname@example.org |
||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 September 18, 2014
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Physiological Effects of Drugs
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action