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
Sponsor:
Information provided by:
Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier:
NCT01345526
First received: April 21, 2011
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Metastatic Colorectal Cancer
Device: Reconval K1 Cream
Device: Reconval Cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Universitätsmedizin Mannheim:

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: 124
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metastatic colorectal cancer, Doxycycline, Vitamin K1 Cream Device: Reconval K1 Cream
Placebo Comparator: Metastatic colorectal cancer, Doxycycline, Cream Device: Reconval Cream

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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

Contacts
Contact: Ralf Hofheinz, Prof. +49 621 383 2855 Ralf.Hofheinz@umm.de

Locations
Germany
Unversity Hospital Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Ralf Hofheinz, Prof.    +49 621 383 2855    Ralf.Hofheinz@umm.de   
Slovenia
Institute of Oncology Ljubljana Not yet recruiting
Ljubljana, Slovenia, 1000
Contact: Janja Ocvirk, Prof.    + 386 15879220    jocvirk@0nko-i.si   
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
Study Chair: Ralf Hofheinz, Prof. Universitätsmedizin Mannheim
  More Information

No publications provided

Responsible Party: Ralf Hofheinz, University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT01345526     History of Changes
Other Study ID Numbers: E-VITA
Study First Received: April 21, 2011
Last Updated: April 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Vitamin K
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Doxycycline
Doxycycline hyclate
Vitamins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on July 28, 2014