Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions

NCT ID: NCT04071756

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-30
• Study Completion Date: 2022-07-14

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).

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

Conditions

Solid Tumor; Hand-Foot Skin Reaction (HFSR)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Topical Tazarotene

Intervention Type: DRUG

This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

A substance that has no therapeutic effect, used as a control in testing new drugs

Interventions

Topical Tazarotene

This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin

Intervention Type: DRUG

Placebo

A substance that has no therapeutic effect, used as a control in testing new drugs

Intervention Type: OTHER

Other Intervention Names

Tazorac

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Nicole LeBoeuf, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicole LeBoeuf, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-099

Identifier Type: -

Identifier Source: org_study_id