ovarian cancer, cancer of the ovary, ovarian carcinoma, carcinoma of the ovary, malignant ovarian tumor, ovarian malignancy, epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer. ovarian cancer
Conditions
Interventions
An additional omental biopsy will be taken 24-48 hours after the second cycle of chemotherapy. 
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a patient must meet all of the following criteria: ? Signed and written informed consent ? Age =18 years and able to understand patient information ? FIGO stage III/IV primary high-grade serous ovarian, fallopian tube, or extra ovarian cancer ? Presence of omental metastases accessible for biopsy ? Residual tissue available of a biopsy from an omental lesion taken prior start of neo-adjuvant chemotherapy ? Planned to receive at least two cycles of neoadjuvant chemotherapy (NACT) with carboplatin plus or minus paclitaxel ? Fit to undergo ultrasound or CT guided biopsy ? Fit for major surgery ? Adequate bone marrow function (hemoglobin level >5.5 mmol/L, leukocytes >3 x10^9/L, platelets > 100x10^9/L)
Exclusion criteria
Exclusion criteria: Previous platinum based chemotherapy, current or recent (within the last 24 months) treatment with targeted therapy or immunotherapy All anticoagulant use that cannot be interrupted or require bridging for biopsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are the amount of platinum in individual cancer cells in an on-treatment biopsy 24-48 hours after the second cycle of systemic carboplatin and paclitaxel treatment; the change in pharmacodynamics markers of carboplatin exposure in individual cancer cells between baseline biopsies (routinely taken for diagnostic purposes) and the on-treatment biopsy (a.o. the change in the level of DNA damage response, as measured by levels of p-H2AX and other markers, in individual cancer cells); the change in the fraction of proliferative cancer cells between baseline and the on-treatment biopsy (as measured by p-Rb, Ki-67 or other markers); the expression levels of proteins that may alter the uptake or effect of carboplatin in ovarian cancer cells, at baseline and in the on-treatment biopsy. The measurements described above, will also be performed in in the patient’s ex vivo tumor fragments before and after ex vivo exposure to carboplatin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the expression of additional markers that can enable the accurate detection of single-cell drug exposure, including immunogenic cell surface proteins on cancer cells, the distance of cancer cells to the nearest blood vessel in the tissue sections, the fraction of cancer cell death, at baseline and in the on-treatment biopsy, and the relative number of CD8+ immune cells and CD68+ immune cells, each at baseline and in the on-treatment biopsy. For the secondary endpoint analyses, these same variables will be measured on tissue obtained during interval cytoreduction. | — |
Countries
Netherlands
Contacts
Public ContactJeany Rademaker - Lakhai
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed