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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00369109

Enrollment

Registered

2006-08-29

Start date

2006-02-28

Completion date

2007-06-30

Last updated

2013-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colorectal Cancer, Pancreatic Cancer

Keywords

recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer, recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer

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.

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.

Interventions

OTHERbiologic sample preservation procedure

OTHERimmunohistochemistry staining method

OTHERlaboratory biomarker analysis

PROCEDUREbiopsy

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026