NCT01299220

Brief Summary

This study will look at if a low-dose regimen of acitretin is helpful in treating a skin rash caused by the chemotherapy drug, erlotinib.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

10 months

First QC Date

February 15, 2011

Last Update Submit

January 14, 2013

Conditions

Skin Rash

Keywords

ErlotinibAcitretinRashDermatologyOncology

Outcome Measures

Primary Outcomes (6)

  • Lesion Counts

    Lesion counts of the identified area of worst involvement will be done in a 5x5 cm area. All subsequent measurements will be done in the same 5x5 cm area.

    Baseline

  • Lesion counts

    Lesion counts in area of worst involvement in 5x5 cm area

    Change from baseline at week 1

  • Lesion counts

    Lesion count is performed in the worst area of involvement in 5x5 cm area

    Change from baseline at week 2

  • Lesion counts

    Lesion count in the area of worst involvement in 5x5 cm area

    Change from baseline at week 4

  • Lesion count

    Lesion counts in area of worst involvement in 5x5 cm area

    Change from baseline at week 8

  • Lesion counts

    Lesion count in area of worst involvement in 5x5 cm area

    Change from baseline at week 12

Secondary Outcomes (6)

  • Quality of Life assessment

    Baseline

  • Quality of Life

    Change from baseline at week 1

  • Quality of Life

    Change from baseline at week 2

  • Quality of Life

    Change from baseline at week 4

  • Quality of Life

    Change from baseline at week 8

  • +1 more secondary outcomes

Interventions

AcitretinDRUG

Acitretin 10 mg by mouth daily

Also known as: Soriatane

Eligibility Criteria

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

You may qualify if:

  • years of age and older at the time of study enrollment.
  • Started routine clinical, palliative, or experimental (off-label) treatment with erlotinib for solid tumors and have developed Grade 2 or higher skin toxicity based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.02.
  • Failed therapy with a two-week course of antibiotic (doxycycline 100 mg twice daily, or cephalexin 250 mg twice daily in patients allergic to doxycycline).
  • Willing and able to provide verbal and written informed consent
  • If reproductive potential, both males and females,must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to enrollment.

You may not qualify if:

  • Pregnant or breast-feeding females.
  • Known or suspected sensitivity to study medication.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 3 or worse.
  • Treatment with a non-approved or investigational drug (with the exception of erlotinib used in an experimental setting) within 30 days prior to Day 1 of study treatment.
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated)for treatment of either a psychiatric or physical (e.g., infectious) illness.
  • Bilirubin greater than or equal to three times the upper limit of normal. Sexually active women of childbearing potential must use an effective method of birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

ExanthemaNeoplasms

Interventions

Acitretin

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Larisa J Geskin, MD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 18, 2011

Study Start

November 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)