Skin Biopsies and DNA Analysis in Patients Receiving Irinotecan or Gemcitabine For Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT00369109|
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : April 8, 2013
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Colorectal Cancer Pancreatic Cancer||Other: biologic sample preservation procedure Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: biopsy|
- 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.
- 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|
|Estimated Enrollment :||60 participants|
|Official Title:||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|
|Study Start Date :||February 2006|
|Primary Completion Date :||November 2006|
|Study Completion Date :||June 2007|
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00369109
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Christie Hospital NHS Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Study Chair:||Patricia M. LoRusso, DO||Barbara Ann Karmanos Cancer Institute|