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

NCT01345526 | Completed Phase 2

• 1 other identifier: E-VITA
• Study Type: interventional
• Target: 124
• Locations: 2 countries
• Sites: 2

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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

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

  Week 8

• PFS rate, toxicity, compliance

  Week 8

Study Arms (2)

Metastatic colorectal cancer, Doxycycline, Vitamin K1 Cream

EXPERIMENTAL

Device: Reconval K1 Cream

Metastatic colorectal cancer, Doxycycline, Cream

PLACEBO COMPARATOR

Device: Reconval Cream

Interventions

Reconval K1 Cream DEVICE

Metastatic colorectal cancer, Doxycycline, Vitamin K1 Cream

Reconval Cream DEVICE

Metastatic colorectal cancer, Doxycycline, Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)).

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (2)

Unversity Hospital Mannheim

Mannheim, 68167, Germany

Location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ralf Hofheinz, Prof.

  Universitätsmedizin Mannheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized Phase II Trial assessing the prevention of acne like Skin rash
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head TTZ University Hospital Mannheim

Model Details: Randomized Phase II trial

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: May 2, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 30, 2021

Record last verified: 2011-04

Locations

SL (1); DE (1)