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

Information source: Universitätsmedizin Mannheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Colorectal Cancer

Intervention: Reconval K1 Cream (Device); Reconval Cream (Device)

Phase: Phase 2

Status: Recruiting

Sponsored by: Universitätsmedizin Mannheim

Official(s) and/or principal investigator(s):
Ralf Hofheinz, Prof., Study Chair, Affiliation: Universitätsmedizin Mannheim

Overall contact:
Ralf Hofheinz, Prof., Phone: +49 621 383 2855, Email: Ralf.Hofheinz@umm.de

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Occurrence of acne-like skin rash grade ≥ 2 (according to the CTCAE version 4.02) during the 8 weeks of skin treatment.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Ralf Hofheinz, Prof., Phone: +49 621 383 2855, Email: Ralf.Hofheinz@umm.de

Unversity Hospital Mannheim, Mannheim 68167, Germany; Recruiting
Ralf Hofheinz, Prof., Phone: +49 621 383 2855, Email: Ralf.Hofheinz@umm.de

Institute of Oncology Ljubljana, Ljubljana 1000, Slovenia; Not yet recruiting
Janja Ocvirk, Prof., Phone: + 386 15879220, Email: jocvirk@0nko-i.si

Additional Information

Starting date: April 2011
Last updated: April 28, 2011

Page last updated: August 23, 2015

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