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Feasibility Study of Biomarker Development for Response Prediction by Large Scale DNA Mutational Analysis of Metastatic Lesions

18 Years
Open (Enrolling)
Neoplasm Metastasis

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Trial Information

Feasibility Study of Biomarker Development for Response Prediction by Large Scale DNA Mutational Analysis of Metastatic Lesions

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

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.

Exclusion Criteria:

Patients not meeting all of the above inclusion criteria.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

Change in radiological volume of the index lesion after the first 2 cycles of irinotecan. Radiological response (according to RECIST 1.1) after the first 2 cycles of irinotecan (i.e. after 2 x 3 weeks = 6 weeks)

Safety Issue:


Principal Investigator

Miriam Koopman, MD/PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC Utrecht


Netherlands: Medical Ethics Review Committee (METC)

Study ID:




Start Date:

May 2011

Completion Date:

May 2014

Related Keywords:

  • Neoplasm Metastasis
  • Feasibility studies
  • Sequence analysis, DNA
  • Biological markers
  • Solid tumors
  • Neoplasm metastasis
  • Irinotecan
  • Pharmacokinetics SN-38
  • Carboxylesterase activity within metastasis
  • Neoplasms
  • Neoplasm Metastasis