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Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01802905
First Posted: March 4, 2013
Last Update Posted: February 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
BC Cancer Foundation
Information provided by (Responsible Party):
British Columbia Cancer Agency
  Purpose
Most systemic therapies are chosen on the basis of large randomized clinical trials; however, tumour heterogeneity means that cancers with similar histological features may have substantially different underlying biological drivers. The investigators propose that applying personal genomic information prospectively obtained in a clinically realistic timeframe to assist in chemotherapy decision-making could result in more effective and efficient cancer treatment. This study will investigate this approach in a cross section of advanced cancers to examine timeliness, deliverability, rate of actionable targets identified, and our ability to expand this approach into a larger clinical trial setting.

Condition Intervention
Advanced Incurable Cancers Genetic: in depth genomic sequencing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies

Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • Frequency of actioanble genomic abnormalites detected that modify treatment [ Time Frame: up to 24 months ]
    What is the frequency of "actionable" results in this varied tumour population ?


Secondary Outcome Measures:
  • What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test [ Time Frame: up to 24 months ]
    What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test.
Enrollment: 100
Study Start Date: June 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequenced patients
Patients enrolled on the study who have successful sequencing of their cancers will be closely monitored for: what chemotherapy agents are next used, what response and toxicity do they have, is there any early sign of response detected on PET-CT, overall did the genomic information change treatment decision-making.
 Genetic: in depth genomic sequencing
Fresh tumour biopsies and matched normal specimens (blood and surrounding tissue) and when possible archival pretreatment specimens, will undergo in depth DNA and RNA sequencing and analysis on an oncogene panel.

Detailed Description:

It is clear that carcinogenesis is an immensely complex process and that even within a histologic cancer subtype - such as adenocarcinoma of the lung or breast - there is significant heterogeneity in cancer behaviour and response to therapy. Recognizing genetic mutations that promote disease facilitates targeted treatment; this has been demonstrated in several small subgroups of cancers in which specific genetic mutations or translocations have been successfully treated with targeted chemotherapy agents.

Analyses of individual patients demonstrate unique molecular signatures for every cancer examined. Frequently, multiple different pathways are involved in disease growth and progression and the dominant process varies from person to person and perhaps even within different sites of disease within one person. As well these variations evolve in response to treatment. With many recognized mutations personalized evaluation of the genetic signature encoded in DNA and RNA may enable directed therapy to the appropriate oncologic pathway thereby providing information to help guide chemotherapy choices.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have histologically or cytologically confirmed diagnosis of cancer
  2. This cancer must be incurable, as defined by their treating oncologist (generally because of advanced stage).
  3. Subjects must agree to provide archival tissue and agree to undergo a study specific biopsy and blood test for genetic analysis. All subjects would have a biopsy and blood samples at progression if it could be done safely.
  4. ECOG PS 0 or 1.
  5. Age > 18 years of age.
  6. Subject consent must be obtained according to the BCCA requirements.
  7. Subject must be accessible for treatment and follow-up. Subjects must be registered at the BCCA Vancouver site.

Exclusion Criteria:

  1. Unable or unwilling to undergo tumour biopsy(s) and/or blood/skin samples for normal DNA.
  2. Significant medical condition that in the opinion of the treating oncologist renders the subject not suitable for participation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802905


Locations
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada
Sponsors and Collaborators
British Columbia Cancer Agency
BC Cancer Foundation
Investigators
Principal Investigator: Janessa J. Laskin, MD FRCPC British Columbia Cancer Agency
Principal Investigator: Marco Marra, PhD FRSC Genome Sciences Centre, BC Cancer Agency
  More Information

Publications:
Peixoto RD; Li Y; Pleasance E; Yip S; et al. A case of the utilization of genomic information in the management of metastatic colorectal cancer. J Clin Oncol 30: 2012 (suppl 34; abstr 444)

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01802905     History of Changes
Other Study ID Numbers: BCCA POG 01
First Submitted: February 27, 2013
First Posted: March 4, 2013
Last Update Posted: February 5, 2015
Last Verified: February 2013

Keywords provided by British Columbia Cancer Agency:
neoplasm
metastatic cancer
cancer genome
genomic analysis
adults


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