Status:
TERMINATED
Biomarker Development for Response Prediction by DNA Mutational Analysis
Lead Sponsor:
P.O. Witteveen
Collaborating Sponsors:
Erasmus Medical Center
The Netherlands Cancer Institute
Conditions:
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to determine whether it is possible to predict response to chemotherapy in patients with metastatic cancer who are treated with irinotecan by determining the mutational pr...
Eligibility Criteria
Inclusion
- Patients with a metastatic solid tumor who have failed at least one line of palliative chemotherapy and are irinotecan naïve.
- Patients who are, as per local protocol, eligible for palliative treatment with (standard of care) irinotecan.
- Measurable metastatic lesion(s), according to RECIST 1.1 criteria.
- Radiological measurable metastatic lesion(s) of which a histological biopsy can safely be obtained:
- Patients with safely accessible metastases.
- Patients not known with bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgeries.
- Patients not using any anti-coagulant medication at the time of biopsy: all aspirin derivatives, NSAID's, coumarines, platelet function inhibitors, heparins (including LMWHs) and oral factor Xa inhibitors are not allowed, unless medication can either be safely stopped or counteracted.
- Adequate coagulation status on the day of biopsy as measured by:
- PTT \< 1.5 x ULN
- APTT \< 1.5 x ULN
- Platelet count 100 x 10\*9 / L or higher
- PT-INR \< 1.6
- HB \> 6
- Biopsies should be performed at least four weeks after last bevacizumab administration.
- Patients age 18 years or up, willing and able to comply with the protocol as judged by the investigator with a signed informed consent.
Exclusion
- Patients not meeting all of the above inclusion criteria.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01855061
Start Date
May 1 2011
End Date
August 1 2016
Last Update
March 9 2018
Active Locations (3)
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1
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, North Holland, Netherlands, 1066 CX
2
Erasmsus Medical Center - Daniël den Hoed clinic
Rotterdam, South Holland, Netherlands, 3075 EA
3
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX