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Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions

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ClinicalTrials.gov Identifier: NCT04071756
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Nicole LeBoeuf, Dana-Farber Cancer Institute

Brief Summary:
This research is studying the preventative use of topical 0.1% tazarotene gel daily in addition to best practice standards to reduce the development of hand-foot skin reaction (HFSR).

Condition or disease Intervention/treatment Phase
Solid Tumor Hand-Foot Skin Reaction (HFSR) Drug: Topical Tazarotene Other: Placebo Phase 2

Detailed Description:

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The U.S. Food and Drug Administration (FDA) has not approved tazarotene for specifically for hand-foot skin reaction but it has been approved for other uses.

In this research study, the investigators are:

-aiming to determine if the use of tazarotene gel daily, in addition to best practice standards:

  • reduces the development of HFSR.
  • decreases modification of regorafenib dose due to HFSR
  • improves health-related quality of life associated with HFSR
  • decreases stress associated with HFSR

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Double-Blind Trial of Topical Tazarotene 0.1% Gel Versus Placebo Gel for the Prevention of Regorafenib-Induced Hand-Foot-Skin Reaction
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
Drug Information available for: Tazarotene

Arm Intervention/treatment
Experimental: Topical Tazarotene 0.1% Gel Plus BPS
  • Pharmacy teaching call
  • DFCI approved teaching sheets will be provided
  • 20% urea applied to the palms and soles in the morning + tazarotene 0.1% gel, applied to the palms and soles nightly
Drug: Topical Tazarotene
This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin
Other Name: Tazorac

Placebo Comparator: Placebo Gel Plus BPS
  • A substance that has no therapeutic effect, used as a control in testing new drugs
  • Pharmacy teaching call
  • DFCI approved teaching sheets will be provided
  • 20% urea applied to the palms and soles in the morning with placebo gel applied in the evening.
Other: Placebo
A substance that has no therapeutic effect, used as a control in testing new drugs




Primary Outcome Measures :
  1. The Proportion of Patients in Each Arm Who Develop Grade-2 or Higher HFSR Within The First 8 Weeks of Protocol Therapy [ Time Frame: 8 weeks ]
    Measured via examination by a Dermatology Provider and grading according to CTCAE version 5

  2. The Proportion of Patients in Each Intervention Arm Who Develop HFSR of Any Grade [ Time Frame: 2 years ]
    Measured via examination by a Dermatology Provider and grading according to CTCAE version 5


Secondary Outcome Measures :
  1. Investigation of whether tazarotene plus BPS improves the impact of HFSR symptoms as measured by differences in HFS-14 scores [ Time Frame: 2 years ]
    Measured using validated "Hand-Foot Syndrome 14 (HFS-14) outcome tool

  2. Investigation of whether the intervention decreases global stress associated with HFSR [ Time Frame: 2 years ]
    Measured using validated 10 question "Perceived Stress Scale" which assesses global stress (regardless of source). This 10 question survey uses a 0-4 scale with higher composite score corresponding to greater stress.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed solid tumors with a plan to initiate regorafenib via dose escalation protocol describe in the ReDOS study in CRC. The ReDOS study recommends this dose escalation of regorafenib:80mg daily x 1 week, 120mg daily x 1 week, 160mg daily times one week, off week, then 160mg daily goal, or maximum tolerated dose thereafter. This is not a separate study; this is the current standard of care for regorafenib dosing. In addition, to compare across the cohorts, patients must be ambulatory with full use of all 4 distal extremities.
  • Age ≥ 18
  • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
  • Participants must have normal organ and marrow function as defined below:

    • leukocytes ≥3,000/mcL
    • absolute neutrophil count ≥1,500/mcL
    • platelets ≥100,000/mcL
    • total bilirubin within normal institutional limits
    • AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
    • creatinine within normal institutional limits OR
    • creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
  • Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation Tazarotene is known to be teratogenic, although the dose required with topical application to affect the developing human fetus is unknown. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of administration.
  • Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test.
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Regorafenib use in combination with another TKI
  • Pregnancy or non-compliance with contraception (4 weeks before, during and for at least 3 ovulatory cycles after treatment cessation). Pregnant women are excluded from this study because tazarotene is category X with the potential for teratogenic or abortifacient effects.
  • Nursing or lactating: Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tazarotene, breastfeeding should be discontinued if the mother is treated.
  • A history of hypervitaminosis A
  • Other systemic retinoids needed for another condition (ie. Isotretinoin for inflammatory acne, acitretin for psoriasis, bexarotene for CTCL).
  • Need for treatment dose systemic steroids or systemic immunosuppressive agents (i.e., for autoimmune disease or cerebral edema) at the time of enrolment
  • Psoriasis or other autoimmune disease requiring skin directed or systemic therapy known to impact keratinocyte proliferation (UV therapy to the hands or feet, TNF inhibitors, etc).
  • Active skin disease of the hands or feet with redness, scaling or blisters prior to enrolment
  • Participants who have had any systemic chemotherapy or immunotherapy within 4 weeks prior to entering the study AND who have not recovered from adverse events on the hands and feet due to the agents administered.
  • Participants who are receiving any other investigational agents to treat HFSR.
  • Uncontrolled intercurrent illness including, but not limited to, uncontrolled lower extremity edema, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071756


Contacts
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Contact: Nicole LeBoeuf, MD 617-632-6361 Nicole_Leboeuf@dfci.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Nicole LeBoeuf, MD    617-632-6361    Nicole_Leboeuf@dfci.harvard.edu   
Principal Investigator: Nicole LeBoeuf, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Bayer
Investigators
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Principal Investigator: Nicole LeBoeuf, MD Dana-Farber Cancer Institute

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Responsible Party: Nicole LeBoeuf, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04071756     History of Changes
Other Study ID Numbers: 19-099
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nicole LeBoeuf, Dana-Farber Cancer Institute:
Solid Tumor
Hand-Foot Skin Reaction (HFSR)
Additional relevant MeSH terms:
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Nicotinic Acids
Tazarotene
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs