Signal TrAnsduction Pathway Activity Analysis in OVarian cancER (STAPOVER)
Recurrent Ovarian Cancer, Signal Transduction Pathway Deregulation, Therapy-Associated Cancer
About this trial
This is an interventional treatment trial for Recurrent Ovarian Cancer focused on measuring Ovarian Cancer, Signal Transduction Pathway, Targeted therapy, Drug repurposing
Eligibility Criteria
Inclusion Criteria:
- Female, age > 18 years
- Patients with recurrent ovarian cancer who meet one of the following criteria:
- Platinum-resistant disease, defined as disease recurrence or progression within six months of last platinum-based chemotherapy or;
- Patient refrains from standard therapy or;
- Asymptomatic patient who is not yet eligible for standard palliative chemotherapy but has an increase of CA125 tumour marker at two consecutive time points 28 days apart with a value of two times nadir above 35 U/ml.
- Progressive disease after at least one prior line of systemic treatment for recurrent disease.
- Radiologically evaluable disease according to RECIST 1.1 criteria (36).
- Ability and willingness to obtain a tumour biopsy after the last course of standard treatment and before start of the study.
- Ability and willingness to provide written and oral consent.
- Able to speak and understand the Dutch language.
- WHO performance status 0-II.
- Adequate renal and liver function to start matched targeted therapy (according to the local clinician).
- Adequate use of contraceptives in case of patients with childbearing potential.
Exclusion Criteria:
- Age < 18 years.
- Patient is receiving any other anti-cancer therapy (e.g. cytotoxic or targeted drug or radiation) or is chemotherapy naïve. The required wash out period prior to start of matched targeted therapy is at least three weeks.
- Patient is diagnosed with or treated for a second primary tumour (except non-melanoma skin tumour) one year prior to study inclusion.
- Inability to obtain (sufficient) tumour material.
- Previous use of the selected targeted drug as anti-cancer agent.
- Physical condition WHO III-IV.
- Pregnant or lactating women.
- Simultaneous participation in another treatment-related clinical trial.
- Patients with any other clinically significant medical condition which, in the opinion of the local clinician, makes it undesirable for the patient to participate in this study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, severe psychiatric illness, or complicated social situations.
Sites / Locations
- Catharina ZiekenhuisRecruiting
- Radboudumc
- Amphia Hospital
- Maastricht UMC+
- Erasmus MC
- Elisabeth-Tweesteden Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
A - ER active tumors
B - AR active tumors
C - PI3K active tumors
D - HH and/or PI3K active tumors
In case of an aberrantly active Estrogen Receptor (ER) pathway, patients will be treated with Letrozole 2.5mg daily orally until progression of disease.
In case of an aberrantly active androgen receptor (AR) pathway, patients will be treated with Bicalutamide 150mg daily orally until progression of disease.
In case of an aberrantly active phosphoinositide 3-kinase (PI3K) pathway, patients will be treated with Everolimus 10mg daily orally until progression of disease.
In case of an aberrantly active Hedgehog (HH) or PI3K pathway, patients will be treated with Itraconazole 300mg twice daily orally until progression of disease.