Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia

Inclusion Criteria

• Adult patients at least 18 years of age
• Able to fully understand and participate in the informed consent process
• Patients who are scheduled to receive a taxane-based regimen for a histologically confirmed solid tumor that is:
• Early stage and/or treatment naïve, or
• Relapsed or is refractory to previous therapy, or
• Operable and necessitates adjuvant or neo-adjuvant treatment
• Have no evidence of alopecia or mild alopecia (NCI CTCAE v.4.0 grade 1 alopecia defined as hair loss of 1500 cells/mm3 within 72 hours prior to registration
• Has serum calcium less than or equal to upper limit of normal (ULN) (for patients with an albumin lower than 3.0, a corrected calcium serum calcium = serum calcium +[0.8][3.5-serum albumin]) within 72 hours prior to registration

Exclusion Criteria

• Patients receiving calcium-lowering therapy or drugs that may affect calcium levels (e.g., calcitonin, mithramycin, phosphate, denosumab) within 4 weeks of initiation of topical calcitriol. Patients who have been managed with bisphosphonates or calcium-lowering therapy for 3 months or greater prior to the start of the trial and have demonstrated evidence for stability of calcium metabolism would be considered eligible for participation in the trial.
• Has a history of drug or alcohol abuse within 1 year of study enrollment as determined by the investigator.
• Patients who elect to shave the scalp hair prior to the initiation of chemotherapy or who plan to do so during the chemotherapy treatment.
• Any dermatological condition that in the opinion of the investigator will affect the absorption of the study medication, e.g. Atopic Dermatitis, etc.
• Has been treated with an investigational agent within 30 days or six half-lives of its biologic activity whichever is longer, before the start of study. (Patients may not be concurrently enrolled on another trial or concurrently treated with another investigational agent)
• Patients with a history of hypercalcemia or vitamin D toxicity, or hospitalization for treatment of angina, myocardial infarction, or congestive heart failure or psychiatric illness currently or within 30 days of study entry as determined by the investigator.
• Has a history of significant allergy to calcitriol as determined by the investigator.
• Has any condition that interferes with the ability of the subject to understand or comply with the requirements of the study.
• Patients taking Vitamin D supplements during the study, unless they have been taking Vitamin D supplements for 30 days or more prior to the start of the study and that the dose of the Vitamin D supplement remain the same throughout the study.
• Patients treated with medications that are known to affect calcium levels within 4 weeks of initiation of topical therapy (>500 IU vitamin A, calcium supplements, fluoride, antiepileptics).with the exception of patients on stable therapy for more than six months
• Patients with hypercalcemia or kidney stones
• Patients that indicate they have significant hair breakage or hair damage and associated hair loss from hair over-processing within the last 30 days due to peroxide applications, permanent hair coloring, bleaches, streaking, perms, relaxers and/or hair oxidative dyes.
• Current alopecia grade 2 or greater as per NCI-CTCAE v.4.0, or significant hair loss or hair breakage
• Prior radiation to the cranium
• Pregnant or breastfeeding