NCT01668498

Brief Summary

80 - 90 % of the patients treated with anti-EGFR antibodies (panitumumab or cetuximab) experience skin toxicity, mostly acne like skin rash. A standardized treatment of skin rash is neither established as standard arm for clinical trials nor as guideline for the treatment of skin toxicity in clinical practice. While an improvement of QoL has been demonstrated for panitumumab and cetuximab in comparison to best supportive care the data basis for patient related outcomes regarding skin toxicity deriving from randomized trials is still small. Recent surveys among German oncologist revealed that physicians are reluctant to use oral antibiotics as preemptive treatment . Only 19 out of 110 oncologists stated that they are thinking about using preemptive treatment in patients with acne-like skin rash. Thus, in the present trial two main questions will be addressed: (i) Can preemptive treatment with oral doxycycline be replaced by a sequential skin treatment strategy (i.e. local treatment with erythromycin followed by doxycycline in case of inefficacy = development of acne) without compromising treatment efficacy of skin toxicity treatment? (ii) Comparison of general and skin related QoL between both treatment arms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

3.7 years

First QC Date

August 16, 2012

Last Update Submit

April 18, 2016

Conditions

Ras-wildtype Colorectal Cancer

Keywords

Can preemptive treatment of panitumumab mediated skintoxicity with oral doxycycline be replaced by local treatment with erythromycin?Panitumumab

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients developing no skin toxicity ≥ grade 2

    Percentage of patients developing no skin toxicity ≥ grade 2 at any time during their first 8-weeks of treatment with panitumumab.

    8 weeks

Secondary Outcomes (5)

  • Quality of life

    8 weeks

  • Assess Skin toxicity

    8 weeks

  • Correlation between skin-related and global quality of life

    8 weeks

  • late skin toxicity

    from week 8 to 12

  • Skin-toxicity related dose reductions of panitumumab

    8 weeks

Study Arms (2)

Erythromycin

EXPERIMENTAL

Experimental Arm (ARM A) skin- treatment: erythromycin cream 2% daily at bedtime doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2 skin moisturizer daily at morning, sunscreen before going outdoors for 8 weeks

Drug: Erythromycin

Doxycyline

ACTIVE COMPARATOR

Standard Arm (ARM B) skin- treatment:doxycycline 100mg b.i.d. skin moisturizer daily at morning, sunscreen before going outdoors for 8 weeks

Drug: Doxycycline

Interventions

ErythromycinDRUG

Comparison of efficacy of Arm A erythromycin cream 2% daily at bedtime (doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2) and Arm B doxycycline 100mg b.i.d. in patients with Metastatic Colorectal cancer (Ras wild-type)being treated with panitumumab.

Also known as: Aknemycin
Erythromycin
DoxycyclineDRUG

Comparison of efficacy of Arm A erythromycin cream 2% daily at bedtime (doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2) and Arm B doxycycline 100mg b.i.d. in patients with Metastatic Colorectal cancer (Ras wild-type)being treated with panitumumab.

Doxycyline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with wild-type RAS (KRAS and NRAS) status of metastatic colorectal cancer treatment with panitumumab according to label
  • RAS wild-type tested in
  • KRAS exon 2 (codons 12/13)
  • KRAS exon 3 (codons 59/61)
  • KRAS exon 4 (codons 117/146)
  • NRAS exon 2 (codons 12/13)
  • NRAS exon 3 (codons 59/61)
  • NRAS exon 4 (codons 117/146)
  • treatment with pre-emptive study medication shall begin the day before treatment start with panitumumab
  • Willingness to cope with biweekly quality of life questionnaires
  • Written Informed consent
  • Aged at least 18 years
  • ECOG Performance Status 0-2
  • Life expectancy of at least 12 weeks
  • Adequate haematological, hepatic, renal and metabolic function parameters:
  • +9 more criteria

You may not qualify if:

  • Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
  • Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
  • Serious concurrent diseases
  • Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment.
  • History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  • History of HIV infection.
  • Other previous or concurrent malignancy (≤ 5 years prior to enrolment in study) except non-melanoma skin cancer or cervical carcinoma FIGO stage 0- 1 if the patient is continuously disease-free
  • Known allergic reactions on panitumumab, doxycycline or erythromycin
  • Previous treatment with anti-cancer agents directed against EGFR (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib)
  • Skin rash existing before or due to other reasons than panitumumab treatment
  • Other dermatologic disease that may interfere with correct grading of panitumumab induced skin rash
  • Parallel treatment with anti-tumor agents other than panitumumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Mannheim, III. Medizinische Klinik

Mannheim, 68167, Germany

Location

Related Links

MeSH Terms

Interventions

Erythromycinerythromycin, ammonium bituminosulfonate drug combinationDoxycycline

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Melanie Kripp, Dr. med.

    III. Medizinische Klinik, Universitätsmedizin Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2012

First Posted

August 20, 2012

Study Start

May 1, 2011

Primary Completion

January 1, 2015

Study Completion

March 1, 2016

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

DE(1)