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

Not Applicable

Completed

• Conditions: Advanced Incurable Cancers
• Interventions: Genetic: in depth genomic sequencing

• Registration Number: NCT01802905
• Lead Sponsor: British Columbia Cancer Agency

Brief 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.

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.

Study Timeline

• Study Start: 2012-06
• Status Verified: 2013-02
• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-04
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-04
• Last Update Posted: 2015-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sequenced patients	in depth genomic sequencing	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.

Primary Outcome Measures

Name	Time	Method
Frequency of actioanble genomic abnormalites detected that modify treatment	up to 24 months	What is the frequency of "actionable" results in this varied tumour population ?

Secondary Outcome Measures

Name	Time	Method
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	What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test.

Trial Locations

Locations (1)

BC Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada