Study of Changes and Characteristics of Genes in Patients With Pancreatic Cancer for Better Treatment Selection (COMPASS)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Researchers are looking for better ways of understanding and treating pancreatic cancer. The purpose of this study is to see how useful it is to look for changes and characteristics in your genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour. These characteristics may be useful in choosing treatments for patients in the future. Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with advanced pancreatic ductal adenocarcinomas and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.

Condition or disease	Intervention/treatment
Carcinoma, Pancreatic Ductal	Genetic: Molecular Profiling

Study Design

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Study Type :	Observational
Estimated Enrollment :	180 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Comprehensive Molecular Characterization of Advanced Pancreatic Ductal Adenocarcinomas (PDAC) for Better Treatment Selection: A Prospective Study
Study Start Date :	December 2015
Estimated Primary Completion Date :	February 2021
Estimated Study Completion Date :	December 2021

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Patients with advanced pancreatic ductal adenocarcinoma	Genetic: Molecular Profiling; Whole Genome Sequencing

Outcome Measures

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Primary Outcome Measures :

1. The feasibility of prospectively identifying subgroups of patients with advanced PDAC who have distinct genomic characteristics for better treatment selection while undergoing 1st-line chemotherapy using next generation sequencing. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :

1. Disease control rate achieved by m-FOLFIRINOX [ Time Frame: 5 years ]
2. Disease control rate achieved by nab-paclitaxel [ Time Frame: 5 years ]
3. Duration of response defined as the interval between the first date of complete response or partial response and the earliest date of disease progression or death due to any cause to m-FOLFIRINOX [ Time Frame: 5 years ]
4. Duration of response defined as the interval between the first date of complete response or partial response and the earliest date of disease progression or death due to any cause to nab-paclitaxel. [ Time Frame: 5 years ]
5. Progression free survival defined as the interval between the date of registration and the earliest date of disease progression or death due to any cause of patients treated with m-FOLFIRINOX. [ Time Frame: 5 years ]
6. Progression free survival defined as the interval between the date of registration and the earliest date of disease progression or death due to any cause of patients treated with nab-paclitaxel. [ Time Frame: 5 years ]
7. Overall survival defined as the interval between the date of registration and the date of death of patients treated with m-FOLFIRINOX [ Time Frame: 5 years ]
8. Overall survival defined as the interval between the date of registration and the date of death of patients treated with nab-paclitaxel. [ Time Frame: 5 years ]
9. Correlation between tumor genomic characteristics and m-FOLFIRINOX response using next generation sequencing. [ Time Frame: 5 years ]
10. Correlation between tumor genomic characteristics and nab-paclitaxel response using the next generation sequencing. [ Time Frame: 5 years ]
11. Percentage of patients with germline BRCA, PALB2 and ATM mutations who might benefit from a personalized treatment strategy such as combination of cisplatin and a PARP inhibition. [ Time Frame: 5 years ]
12. Percentage of patients with somatic DSBR deficiency who might benefit from a personalized treatment strategy such as combination of cisplatin and a PARP inhibitor. [ Time Frame: 5 years ]
13. Percentage of patients who might benefit from immunotherapy (patients with smoking genomic signatures, patients with a hypermutated phenotype, patients with mismatch repair deficiency and patients with tumor neo-antigen expression). [ Time Frame: 5 years ]
14. Percentage of patients with rare but targetable somatic mutations. [ Time Frame: 5 years ]
15. Difference in disease control rate between patients with tumor smoking signature and those without. [ Time Frame: 5 years ]
16. Difference in overall survival between patients with tumor smoking signature and those without. [ Time Frame: 5 years ]
17. Correlation with tumor molecular characteristics and toxicities to treatment using next generation sequencing. [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA

• Fresh tumor tissue biopsy samples
• Archival tumor tissue samples
• Whole blood samples
• Plasma samples
• Serum samples

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Population

Locally advanced or metastatic pancreatic ductal adenocarcinoma

Criteria

Inclusion Criteria:

• Patients must have a histological or radiological diagnosis of locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with borderline resectable disease are not eligible.
• Patient must have a tumor lesion that is amenable to a core needle biopsy.
• Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
• Patients must be fit enough to safely undergo a tumor biopsy.
• Age 18 years or older.
• Eastern Cooperative Group (ECOG) performance status of 1 or less.
• Life expectancy of greater than 90 days.
• Patients must have normal organ and marrow function
• Patients must undergo systemic treatment with m-FOLFIRINOX or nab-paclitaxel as a first line standard systemic palliative treatment or combination treatment with m-FOLFIRINOX or nab-paclitaxel with or without other investigational agents within a clinical trial as a first line palliative treatment.
• Ability to understand and willing to sign a written informed consent document.

Exclusion Criteria:

• Patients with one or more contraindications to tumor biopsy.
• Patients who have prior systemic treatment (chemotherapy or any other anti-cancer agent) in advanced setting.
• Patients who are currently on anti-cancer treatment including chemotherapy.
• Patients with known brain metastases.
• Patients with advanced PDAC who are going to be treated with gemcitabine monotherapy in advanced setting.
• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Jennifer J. Knox, M.D	416-946-2399

Locations

Canada, Ontario
Princess Margaret Cancer Centre	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Jennifer J. Knox, M.D. 416-946-2399
Principal Investigator: Jennifer J. Knox, M.D.

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:	Jennifer J. Knox, M.D.	Princess Margaret Cancer Centre

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT02750657 History of Changes
Other Study ID Numbers:	COMPASS-001
First Posted:	April 25, 2016
Last Update Posted:	February 14, 2018
Last Verified:	February 2018

Additional relevant MeSH terms:

Carcinoma, Pancreatic Ductal; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary	Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases