Biomarker Development for Response Prediction by DNA Mutational Analysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2016-08-31

Brief Summary

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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 profile of the tumor.

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Detailed Description

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Conditions

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Neoplasm Metastasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Irinotecan

Patients will be subjected to a their metastatic solid tumor. Radiological response will be evaluated after each 2 cycles: 1. percentage change in radiological volume of the "index lesion" (radiological measurable lesion that underwent biopsy) after the first two cycles of irinotecan; 2. radiological response according to RECIST 1.1 after each 2 cycles. Patients are intended to receive irinotecan until progressive disease or unacceptable toxicity. Patients will be subjected to another biopsy of the index lesion at definitive discontinuation of irinotecan. Patients will also be subjected to blood draws for determining patient's genetic background variation.

Side studies include:

* pharmacogenetics
* pharmacokinetics of SN-38
* carboxylesterase activity in the index lesion
* midazolam clearance test (only in Rotterdam patients)

Midazolam clearance test

Intervention Type PROCEDURE

Patients who are being treated in Rotterdam will be subjected to blood draws for validation of the earlier developed midazolam phenotyping test (midazolam clearance test), which may be an indicator for pharmacokinetics of irinotecan.

Biopsy

Intervention Type PROCEDURE

Histological biopsy of the "index lesion" (a radiological measurable lesion on which biopsy is performed) at baseline, as well as when showing progressive disease. Histological biopsies will be subjected to DNA sequencing to assess the mutational profile, as well as to analysis of carboxylesterase activity.

Blood samples

Intervention Type PROCEDURE

Blood samples will be taken at baseline to determine patient's genetic background variation (germline DNA).

Pharmacokinetics

Intervention Type PROCEDURE

Blood samples will be taken for pharmacokinetic analysis of the active irinotecan metabolite (SN-38).

Interventions

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Midazolam clearance test

Patients who are being treated in Rotterdam will be subjected to blood draws for validation of the earlier developed midazolam phenotyping test (midazolam clearance test), which may be an indicator for pharmacokinetics of irinotecan.

Intervention Type PROCEDURE

Biopsy

Histological biopsy of the "index lesion" (a radiological measurable lesion on which biopsy is performed) at baseline, as well as when showing progressive disease. Histological biopsies will be subjected to DNA sequencing to assess the mutational profile, as well as to analysis of carboxylesterase activity.

Intervention Type PROCEDURE

Blood samples

Blood samples will be taken at baseline to determine patient's genetic background variation (germline DNA).

Intervention Type PROCEDURE

Pharmacokinetics

Blood samples will be taken for pharmacokinetic analysis of the active irinotecan metabolite (SN-38).

Intervention Type PROCEDURE

Other Intervention Names

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Histological biopsy Blood sampling PK Pharmacokinetic analysis Pharmacokinetic analyses MCT

Eligibility Criteria

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Inclusion Criteria

1. Patients with a metastatic solid tumor who have failed at least one line of palliative chemotherapy and are irinotecan naïve.
2. Patients who are, as per local protocol, eligible for palliative treatment with (standard of care) irinotecan.
3. Measurable metastatic lesion(s), according to RECIST 1.1 criteria.
4. Radiological measurable metastatic lesion(s) of which a histological biopsy can safely be obtained:

1. Patients with safely accessible metastases.
2. Patients not known with bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgeries.
3. 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.
4. 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
5. Biopsies should be performed at least four weeks after last bevacizumab administration.
5. Patients age 18 years or up, willing and able to comply with the protocol as judged by the investigator with a signed informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No