Skin Biopsies and DNA Analysis in Patients Receiving Irinotecan or Gemcitabine For Advanced Solid Tumors
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|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|
|Actual Primary Completion Date :||November 2006|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|