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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00369109
• Other study ID #: CDR0000479118
• Secondary ID: P30CA022453WSU-2
• Status: Completed
• Phase: N/A
• First received: August 24, 2006
• Last updated: April 5, 2013
• Start date: February 2006
• Est. completion date: June 2007

Study information

• Verified date: April 2013
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• biologic sample preservation procedure

• immunohistochemistry staining method

• laboratory biomarker analysis

Procedure:
• biopsy

Locations

Country	Name	City	State
United Kingdom	Christie Hospital NHS Trust	Manchester	England
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Secondary	Characterization of the method for measurement (immunohistochemistry)			No
Secondary	Inter- and intra-patient variability for the biomarker			No
Secondary	Dynamic time course of p-Chk1 and p-H2AX after administration of a DNA-damaging agent			No