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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00369109
First Posted: August 29, 2006
Last Update Posted: April 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
August 24, 2006
August 29, 2006
April 8, 2013
February 2006
November 2006   (Final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00369109 on ClinicalTrials.gov Archive Site
  • 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
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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

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.

Observational
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  • Breast Cancer
  • Colorectal Cancer
  • Pancreatic Cancer
  • Other: biologic sample preservation procedure
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
  • Procedure: biopsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2007
November 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United States
 
 
NCT00369109
CDR0000479118
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2005-039
ZENECA-D1040M00003
WSU-0512003224
No
Not Provided
Not Provided
Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Patricia M. LoRusso, DO Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
April 2013