Biomarker Analysis for Patients With Metastatic Colorectal Cancer (MCC)

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
US Oncology Research
ClinicalTrials.gov Identifier:
NCT01909362
First received: July 19, 2013
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

Patients are being asked to participate in this study who have colorectal cancer that has come back after initial treatment. The investigators want to improve treatment in patients with this disease. In other types of cancers, it has been possible to improve treatment by studying the gene mutations (called biomarkers) in a patient's cancer and "matching" these to existing cancer therapies or study drugs which target that specific mutation. Colorectal cancers have not been routinely tested in this way.

In this study, investigators will determine whether mutational testing can be successfully done on colorectal cancers and how often mutations are detected for which there are existing drugs (or drugs in development). The results will be used to determine if treating physicians use this information in planning subsequent treatment.


Condition
Colorectal Neoplasms
Advanced Metastatic Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Feasibility Study of Biomarker Analysis for Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by US Oncology Research:

Primary Outcome Measures:
  • number of drug targetable genetic changes found in tumor tissue sample [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The frequencies and sites of 47 clinically relevant mutations or amplifications from biospecimens of early and/or late recurrence patients will be tabulated and summarized based on the evaluable population, respectively. The number of clinically actionable mutations with FDA-approved drugs will be compared to the number without and to those with associated clinical trials.


Secondary Outcome Measures:
  • number and cause of failed analyses after registration and tissue submission [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Samples submitted for analysis will be from archived FFPE tissue. Ability to perform the AmpliSeq testing may be limited based on the quality and quantity of the sample available. Reasons for testing failures may be due to an inability to extract sufficient quality and quantity of DNA, inability to create a sequencing library or inability for a sample to sequence. Should a testing failure occur, the reason for the testing failure will be recorded by the laboratory and reported back to the clinician. A patient will have the opportunity, in discussion with their study physician, dependent on space in the study and approval from the US Oncology Clinical Project Manager, be allowed to re-submit one additional sample for sequencing. If a sample from a patient is a testing failure after 2 testing attempts, the patient is considered a permanent testing failure and will not be offered an opportunity to submit any additional samples.

  • number of physicians who took into consideration regimens that were suggested by the results of the sequencing analysis when deciding their patients' next line of therapies. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tumor tissue (biopsy or surgery) retrieved within 4 weeks from the date of signing the ICF and tested as outlined in the protocol:

- FFPE specimen (blocks or cut slides) currently in storage at a pathology lab. Such tissue may be archival and stored, for no more than 5 years, being obtained at the time for a standard of care diagnostic or research biopsy.


Enrollment: 52
Study Start Date: July 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Early recurrence (≤ 12 months)
Biospecimens from 25 patients who have had early recurrence (≤ 12 months) of their metastatic colorectal cancer
Late recurrence (> 12 months)
Biospecimens from 25 patients who have had late recurrence (> 12 months) of their metastatic colorectal cancer

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with metastatic colorectal cancer seen within the US Oncology network

Criteria

Inclusion Criteria:

  1. Has been re-staged to Stage IV colorectal cancer following recurrence after adjuvant chemo-therapy treatment for Stage II or III disease
  2. Primary tumor has been resected prior to the patient being diagnosed with Stage IV disease
  3. Able to submit archival tissue from the patient's resected primary tumor taken prior to diagnosis of metastatic disease
  4. Tumor tissue (biopsy or surgery) was retrieved within 4 weeks from the date of signing the ICF and tested as outlined in the protocol:

    • FFPE specimen (blocks or cut slides) currently in storage at a pathology lab. Such tissue may be archival and stored, for no more than 5 years, being obtained at the time for a standard of care diagnostic or research biopsy.

  5. Is at least 18 years old
  6. Is willing to allow access to clinical and demographic information
  7. Has signed a Patient Informed Consent Form
  8. Has signed a Patient Authorization Form (HIPAA)

Exclusion Criteria:

  1. Is unable or unwilling to provide informed consent for collection and profiling of tumor tissue
  2. PATIENT HAS NOT RECEIVED PRIOR ADJUVANT TREATMENT FOR STAGE II OR III COLORECTAL CANCER OR HAS BEEN ORIGINALLY DIAGNOSED WITH STAGE IV
  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: NCT01909362

Locations
United States, Texas
13 sites within US
incl Greenville, SC and Tyler, TX, Texas, United States
Sponsors and Collaborators
US Oncology Research
Quintiles
Investigators
Principal Investigator: Ki Y. Chung, M.D. US Oncology Research, McKesson Specialty Health
Principal Investigator: Donald A. Richards, M.D., Ph.D US Oncology Research, McKesson Specialty Health
  More Information

Publications:
Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT01909362     History of Changes
Other Study ID Numbers: 12246
Study First Received: July 19, 2013
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by US Oncology Research:
advanced metastatic colorectal cancer
mCRC
Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Genetic mutation testing
Tumor tissue sampling

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 01, 2014