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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


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Colorectal Cancer, Pancreatic Cancer

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

N/A

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

Safety Issue:

No

Principal Investigator

Patricia M. LoRusso, DO

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000479118

NCT ID:

NCT00369109

Start Date:

February 2006

Completion Date:

June 2007

Related Keywords:

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

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201