Feasibility study of biomarker development for response prediction by large scale DNA mutational analysis of metastatic lesions.

Feasibility study of biomarker development for response prediction by large scale DNA mutational analysis of metastatic lesions. - CPCT - 01 trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39548

Enrollment

Registered

2011-05-10

Start date

2011-11-08

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic cancer metastatic solid tumors

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Metastatic colorectal carcinoma or other solid tumors Failed at least one line of palliative chemotherapy Irinotecan naïve Eligible, as per local protocol, for palliative treatment with standard of care irinotecan Measurable metastatic lesion(s) according to RECIST 1.1. criteria Safe biopsy of a radiological measurable lesion possible Adults age 18 years or up Written informed consent

Exclusion criteria

Exclusion criteria: Patients with other malignancies than metastatic colorectal cancer or other solid tumors Patients eligible for first-line treatment Patients who were already subjected to treatment with irinotecan Patients with disease not measurable according to RECIST 1.1. criteria Safe biopsy of radiological measurable lesion not possible Patients younger than 18 years old Patients not willing to sign informed consent

Design outcomes

Primary

Measure	Time frame
Exploration of the correlation between percentage change in volumetric measurement of the index lesion and the mutational profile after the first two cycles of chemotherapy.	—

Secondary

Measure	Time frame
Secondary endpoints: - Exploration of the correlation between radiological response according to RECIST-criteria and the mutational profile after each two cycles of chemotherapy. - Exploration of the correlation between progression free survival and overall survival with the mutational profile. - Explore the correlation between patient*s germline DNA background variation and mutational profile of the metastasis. - Differences in mutational profile of the metastasis prior to and after exposure to treatment. - Determine reliable and valid strategies for statistical analysis for biomarker discovery. Tertiary endpoints: - Correlate response to the pharmacokinetics of SN-38. - Determine carboxylesterase (hCE1 and hCE2) activity in metastatic tumor material (pre- and post-treatment) and correlate intra-tumoral carboxylesterase activity to systemic SN-38 pharmacokinetics and to irinotecan response. - Number and nature of all (serious) adverse events of study related procedures.	—

Measure

Time frame

Secondary endpoints: - Exploration of the correlation between radiological response according to RECIST-criteria and the mutational profile after each two cycles of chemotherapy. - Exploration of the correlation between progression free survival and overall survival with the mutational profile. - Explore the correlation between patient*s germline DNA background variation and mutational profile of the metastasis. - Differences in mutational profile of the metastasis prior to and after exposure to treatment. - Determine reliable and valid strategies for statistical analysis for biomarker discovery. Tertiary endpoints: - Correlate response to the pharmacokinetics of SN-38. - Determine carboxylesterase (hCE1 and hCE2) activity in metastatic tumor material (pre- and post-treatment) and correlate intra-tumoral carboxylesterase activity to systemic SN-38 pharmacokinetics and to irinotecan response. - Number and nature of all (serious) adverse events of study related procedures.

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Countries

Netherlands

Outcome results