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

Advanced Incurable Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802905
• Other study ID #: BCCA POG 01
• Status: Completed
• Phase: N/A
• First received: February 27, 2013
• Last updated: February 4, 2015
• Start date: June 2012
• Est. completion date: February 2015

Study information

• Verified date: February 2013
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Advanced Incurable Cancers

Intervention

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.

Locations

Country	Name	City	State
Canada	BC Cancer Agency	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	BC Cancer Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of actioanble genomic abnormalites detected that modify treatment	What is the frequency of "actionable" results in this varied tumour population ?	up to 24 months	No
Secondary	What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test	What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test.	up to 24 months	No