Know Cancer

forgot password

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.

Phase 2
18 Years
Open (Enrolling)
Metastatic Colorectal Cancer

Thank you

Trial Information

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.

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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Week 8

Safety Issue:


Principal Investigator

Ralf Hofheinz, Prof.

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Mannheim


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

April 2011

Completion Date:

December 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms