Signal TrAnsduction Pathway Activity Analysis in OVarian cancER

Launched by GYNAECOLOGISCH ONCOLOGISCH CENTRUM ZUID · Mar 1, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat women with recurrent ovarian cancer by using a special test that looks at how cancer cells communicate with each other. The goal is to see if certain targeted therapies, which are already known to be safe, can be effective for patients whose cancer has returned after treatment. By matching these therapies to the specific activity of the cancer cells, the hope is to improve survival rates and maintain a good quality of life for participants.

To be eligible for this study, you must be a woman over 18 years old with recurrent ovarian cancer, meaning your cancer has come back after treatment. You could qualify if your cancer has not responded to certain types of chemotherapy or if you have rising tumor markers but are not yet ready for standard treatment. Participants will need to provide a biopsy of their tumor and will receive targeted therapy tailored to their cancer's characteristics. It’s important to note that you cannot be currently receiving other cancer treatments or have certain medical conditions that could interfere with the study. Overall, this trial aims to find more personalized and effective treatment options for women facing recurrent ovarian cancer.

Gender

FEMALE

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.