A Phase I Study of Topical Calcitriol (Compound 31543) to Prevent Hair Loss in Women Receiving Paclitaxel for Advanced Breast Cancer

Protocol
11-205
Full Title
A Multi-Center, Phase I Dose-Escalation Study, to Evaluate the Safety, Tolerability and Pharmacokinetics of a Topical Compound 31543 (Calcitriol, USP) in Adult Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Advanced or Recurrent Disease
Phase
I
Purpose

Paclitaxel is commonly used to treat breast cancer, but is associated with hair loss. In this study, researchers want to determine the highest dose of a topical form of vitamin D (applied to the scalp) called calcitriol (compound 31543) that can be used by women who are receiving paclitaxel for inoperable locally advanced or metastatic breast cancer. It is possible that topical calcitriol may prevent or reduce the hair loss associated with paclitaxel chemotherapy.

Patients will apply the calcitriol cream to the scalp twice daily (morning and evening).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be women with inoperable locally advanced or metastatic breast cancer and be scheduled for treatment with paclitaxel.
  • Patients must have a full head of hair prior to entering the study.
  • Patients must not have a history of hypercalcemia (high blood levels of calcium), kidney stones, or intolerance to vitamin D.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information about this study, please contact Dr. Mario Lacouture at 212-610-0079.

Disease(s)
Breast Cancer
Locations
Related Diseases