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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00369109
First received: August 24, 2006
Last updated: April 5, 2013
Last verified: April 2013

August 24, 2006
April 5, 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 [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00369109 on ClinicalTrials.gov Archive Site
  • Characterization of the method for measurement (immunohistochemistry) [ Designated as safety issue: No ]
  • Inter- and intra-patient variability for the biomarker [ Designated as safety issue: No ]
  • Dynamic time course of p-Chk1 and p-H2AX after administration of a DNA-damaging agent [ Designated as safety issue: No ]
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00369109
CDR0000479118, P30CA022453, WSU-2005-039, ZENECA-D1040M00003, WSU-0512003224
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP