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

Sponsor

Barbara Ann Karmanos Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00369109

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

15.9

Duration (Months)

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Colorectal Cancer Pancreatic Cancer	Other: biologic sample preservation procedure Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: biopsy

Detailed 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.

Study Design

Study Type:

Observational

Anticipated 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 :

Feb 1, 2006

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

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 []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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