Trial Information

Collection of Skin Biopsy With Hair Follicles as Surrogate to Develop Biomarker Assays From Patients With Advanced Solid Tumor Malignancies Receiving Either Single Agent Weekly Irinotecan or Gemcitabine

OBJECTIVES:

Primary

- Determine the level of p-Chk1 and phospho-histone 2AX (p-H2AX), an indicator of DNA
damage, and possibly downstream pathway markers in hair follicles from skin biopsies of
patients treated with gemcitabine hydrochloride or irinotecan hydrochloride for
advanced solid tumors.

Secondary

- Characterize the method for measurement (immunohistochemistry).

- Measure inter- and intra-patient variability for the biomarker.

- Partially characterize the dynamic time course of p-Chk1 and p-H2AX after
administration of a DNA-damaging agent.

OUTLINE: This is a multicenter study.

Patients undergo collection of 2 skin biopsies with hair follicles at 4 and 8 hours or at 4
and 6 hours after the start of irinotecan hydrochloride or gemcitabine hydrochloride
treatment on day 1 of course 1. Repeat biopsies will be taken at 4, 6, or 8 hours after the
start of irinotecan hydrochloride or gemcitabine hydrochloride on day 1 of 2 successive
courses.

Tissue is examined by immunohistochemistry and possibly other methods for changes in p-Chk1
and pH2AX.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.