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Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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.

NCT01345526•Universitätsmedizin Mannheim

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+11 more criteria

Locations (2)

Unversity Hospital Mannheim

Mannheim, Germany

Institute of Oncology Ljubljana

Ljubljana, Slovenia

Key Dates

Start Date

April 1, 2011

Primary Completion Date

December 1, 2016

Completion Date

December 1, 2016

Last Updated

April 30, 2021

Enrollment

124

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

Reconval K1 Cream

DEVICE

Reconval Cream

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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