NCT00369109

Skin Biopsies and DNA Analysis in Patients Receiving Irinotecan or Gemcitabine For Advanced Solid Tumors

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This laboratory study is collecting skin biopsy specimens from patients receiving irinotecan or gemcitabine for advanced solid tumors and using them to study change in DNA due to this treatment.

Detailed description

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.

Conditions

• Breast Cancer
• Colorectal Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
OTHER	biologic sample preservation procedure
OTHER	immunohistochemistry staining method
OTHER	laboratory biomarker analysis
PROCEDURE	biopsy

Timeline

• Start date: 2006-02-01
• Primary completion: 2006-11-01
• Completion: 2007-06-01
• First posted: 2006-08-29
• Last updated: 2013-04-08

Locations

2 sites across 2 countries: United States, United Kingdom