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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Grade 2 or Higher Hand-Foot Skin Reaction (HFSR) Rate
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Topical Tazarotene (Drug)
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.
干预措施: Placebo (Other)
结局指标
主要结局
Grade 2 or Higher Hand-Foot Skin Reaction (HFSR) Rate
时间窗: Up to 8 weeks
Grade 2 or higher hand-foot skin reaction (HFSR) Rate defined as the percentage of patients in each arm who develop grade-2 or higher HFSR within the first 8 weeks of protocol therapy. Measured via examination by a Dermatology Provider and grading according to CTCAE version 5.
All Grade Hand-Foot Skin Reaction (HFSR) Rate
时间窗: Up to 8 weeks
Any grade hand-foot skin reaction (HFSR) Rate defined as the percentage of patients in each arm who develop HFSR within the first 8 weeks of protocol therapy. Measured via examination by a Dermatology Provider and grading according to CTCAE version 5.
次要结局
- Change in Perceived Stress Scale (PSS) From Baseline to Day 56(at baseline and day 56)
- Change in HFS-14 Score From Baseline to Day 56(At baseline and at day 56.)
研究者
Nicole LeBoeuf, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute