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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01345526
Recruitment Status : Unknown
Verified April 2011 by Universitätsmedizin Mannheim.
Recruitment status was:  Recruiting
First Posted : May 2, 2011
Last Update Posted : May 2, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Device: Reconval K1 Cream Device: Reconval Cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : April 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K
Drug Information available for: Doxycycline

Arm Intervention/treatment
Experimental: Metastatic colorectal cancer, Doxycycline, Vitamin K1 Cream Device: Reconval K1 Cream
Placebo Comparator: Metastatic colorectal cancer, Doxycycline, Cream Device: Reconval Cream

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01345526

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Contact: Ralf Hofheinz, Prof. +49 621 383 2855

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Unversity Hospital Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Ralf Hofheinz, Prof.    +49 621 383 2855   
Institute of Oncology Ljubljana Not yet recruiting
Ljubljana, Slovenia, 1000
Contact: Janja Ocvirk, Prof.    + 386 15879220   
Sponsors and Collaborators
Universitätsmedizin Mannheim
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Study Chair: Ralf Hofheinz, Prof. Universitätsmedizin Mannheim
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Responsible Party: Ralf Hofheinz, University Hospital Mannheim Identifier: NCT01345526    
Other Study ID Numbers: E-VITA
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases