Cancer of the ovary ovarian carcinoma
Conditions
Interventions
STA-analysis will be performed on a biopsy taken from the recurrent tumour.
Patients will be included if a predominant pathway is identified for which a
matched targeted drug is available and deemed
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 18 years or older - Patients with recurrent ovarian cancer who meet one of the following criteria: 1. Platinum-resistant disease or; 2. Patients refrains from standard therapy or; 3. Asymptomatic patients who are not yet eligible for standard palliative chemotherapy but have an increase of CA125 tumour marker at two consecutive timepoints 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. - 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
Exclusion criteria: - Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is therapy response defined as PFS2/PFS1 ratio according to RECIST 1.1 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include the proportion of patients with an actionable active pathway and the proportion of patients receiving matched targeted therapy, best overall response (according to RECIST 1.1 criteria), one-year overall survival and overall survival, predictive value of STA-analysis results, side effects, quality of life, cost-effectiveness and change in pathway activity score after disease progression compared to the pathway activity score before the start of targeted therapy. | — |
Countries
Netherlands
Outcome results
None listed