Status:
COMPLETED
Study to Identify Mechanisms of Resistance to Standard Therapy in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Jewish General Hospital
Collaborating Sponsors:
Exactis Innovation
Terry Fox Research Institute
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicenter translational study to understand therapeutic resistance in patients undergoing first-line chemotherapy (FOLFOX/Avastin, or FOLFIRI/Avastin) for metastatic colorectal cancer. Tis...
Detailed Description
The major obstacle to the cure of cancer by pharmacological agents is resistance to these agents. Clinical responses of metastatic cancers to the most advanced chemotherapeutic agents usually range fr...
Eligibility Criteria
Inclusion
- Patients with a histologically confirmed diagnosis of colorectal cancer, with at least one liver metastasis site available for biopsy.
- For patients with liver only disease, patients deemed not to be initially resectable
- Scheduled to receive first-line chemotherapy (FOLFOX/bevacizumab or FOLFIRI/bevacizumab) for metastatic disease.
- Measurable metastatic disease (at least one unidimensionally measurable lesion) present after planned biopsy of metastatic site(s).
- ECOG 0, 1 or 2.
- Life expectancy of 12 or more weeks.
- Age \> 18 years.
- Able to adhere to the study visit schedule and other protocol requirements.
- Normal coagulation profile (PT, PTT, INR).
Exclusion
- Patients with initially resectable liver only metastases
- Have received prior therapy for metastatic cancer. Prior adjuvant therapy is allowed.
- Inadequate or unusable tissue as the only tissue available for biopsy.
- Contraindication to any of the components of the the first-line chemotherapy regimen.
- Known brain metastases or meningeal disease.
- Female patients who are pregnant or breastfeeding.
- Concurrent treatment with other anti-cancer therapy (palliative radiation is allowed but patients must have a metastatic site available for re-biopsy that has not been irradiated).
- Abnormal coagulation profile, any anti-coagulant therapy.
- Known infection with HIV.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00984048
Start Date
August 1 2009
End Date
August 1 2019
Last Update
June 15 2021
Active Locations (15)
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1
University Hospital Leuven
Leuven, Belgium
2
The Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
3
Dr. Georges L. Dumont University Hospital
Moncton, New Brunswick, Canada, E1C 8X3
4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5