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

Barbara Ann Karmanos Cancer Institute60 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer Colorectal Cancer Pancreatic Cancer

Interventions

biologic sample preservation procedureOTHER

immunohistochemistry staining methodOTHER

laboratory biomarker analysisOTHER

biopsyPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of advanced solid tumor malignancy (preferably colorectal, pancreatic, or breast cancer) * Scheduled to receive a standard dose, weekly regimen of either irinotecan hydrochloride or gemcitabine hydrochloride PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * No DNA-damaging agent within the past 13 days

Locations (2)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Christie Hospital NHS Trust

Manchester, England, United Kingdom

Outcomes

Primary Outcomes

Level of p-Chk1 and phospho-histone 2AX (p-H2AX) 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 Outcomes

Characterization of the method for measurement (immunohistochemistry)

Inter- and intra-patient variability for the biomarker

Dynamic time course of p-Chk1 and p-H2AX after administration of a DNA-damaging agent

Data from ClinicalTrials.gov

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