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
  Purpose

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 Intervention
Breast Cancer
Colorectal Cancer
Pancreatic Cancer
Other: biologic sample preservation procedure
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: biopsy

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: February 2006
Study Completion Date: June 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369109

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United Kingdom
Christie Hospital NHS Trust
Manchester, England, United Kingdom, M20 4BX
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Patricia M. LoRusso, DO Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00369109     History of Changes
Other Study ID Numbers: CDR0000479118, P30CA022453, WSU-2005-039, ZENECA-D1040M00003, WSU-0512003224
Study First Received: August 24, 2006
Last Updated: April 5, 2013
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Colorectal Neoplasms
Breast Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Breast Diseases
Skin Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 16, 2014