Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions
Condition: Solid Tumor; Hand-Foot Skin Reaction (HFSR)
Intervention: Topical Tazarotene; Placebo
Intervention description: This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin; A substance that has no therapeutic effect, used as a control in testing new drugs
Intervention MeSH terms: Tazarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid Tumor; Hand-Foot Skin Reaction (HFSR)

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have histologically or cytologically confirmed solid tumors with a
             plan to initiate regorafenib, or having started regorafenib in the last 48 hours, 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 sufficient organ and marrow function in the opinion of the
             treating investigator. This can be based on lab reports from an outside facility.

          -  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 (unless regorafenib was started in the
             last 48 hours)

          -  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.