Niraparib Maintenance in Patients With Advanced Ovarian Cancer at Neoadjuvant Setting

Launched by THE UNIVERSITY OF HONG KONG · Feb 23, 2020

Keywords

ClinConnect Summary

Despite cytoreductive surgery and platinum-based chemotherapy, about 70% of patients with advanced ovarian cancer recur in the first 2 - 3 years. PARPi has been shown to be prolong survival in primary advanced ovarian cancer. However its role in neoadjuvant setting has not been fully evaluated.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must be at least 18 years old.
• • 2. Patients must have newly diagnosed, histologically confirmed high grade, serous or endometrioid, FIGO stage 3 or 4, ovarian, fallopian tube or primary peritoneal carcinoma before the start of NACT.
• • 3. Patients must have received 3 - 4 cycles of NACT containing either carboplatin or cisplatin, IDS with or without HIPEC, and 3 - 6 more cycles of adjuvant chemotherapy, prior to recruitment into the study.
• • 4. The patients should have only one cytoreductive surgery.
• • 5. The patients must show either complete (CR) or partial response (PR) to the platinum-based chemotherapy using RECIST 1.1 criteria.
• • 6. Patients should not be amenable to further surgery or radiotherapy except for the purpose of symptomatic relief.
• • 7. All surgery, chemotherapy and radiotherapy should finish more than 3 weeks prior to recruitment.
• • 8. Niraparib should be started within 8 weeks after the last dose of chemotherapy.
• • 9. Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment.
• • 10. Patients must have adequate bone marrow, renal, hepatic and neurological function within 28 days prior to the start of treatment.
• • 11. Patients who have childbearing potential should practice highly effective contraception throughout the study until at least 30 days after completion of the treatment.
• Exclusion Criteria:
• • 1. Patients who are diagnosed to have low-grade or borderline carcinoma, mucinous or clear cell cystadenocarcinoma, carcinosarcoma or undifferentiated carcinoma, are excluded.
• • 2. Patients who have stable disease or PD on the post-treatment scan or clinical evidence are excluded.
• • 3. Patients who have drainage of ascites within 4 weeks before recruitment are excluded.
• • 4. Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer or in-situ breast cancer) are excluded.
• • 5. Patients who have history of unresolved thrombocytopenia, myelodysplastic syndrome or acute myeloid leukaemia are excluded.
• • 6. Patients who have symptomatic brain or leptomeningeal metastases, or spinal cord compression are excluded unless these are treated and controlled within 28 days of recruitment.
• • 7. Patients with the significant past medical history, such as active hepatitis, myocardiac infarction, in the last six months are excluded.
• • 8. Patients with severe gastrointestinal conditions such as evidence of bowel obstruction in the last 4 weeks prior to enrolment, or history of inflammatory bowel disease, are not eligible.
• • 9. Patients having had severe infections within 4 weeks prior to the start of treatment are excluded.
• • 10. Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded.
• • 11. Patients with prior allogeneic stem cell or solid organ transplantation are excluded.
• • 12. Those patients who suffer from CTCAE grade 2 or more toxicity from previous treatment, except alopecia, are excluded.
• • 13. Patients who have used PARPi previously are excluded.
• • 14. Patients who are allergic to any component of niraparib are excluded.
• • 15. Patients who have used bevacizumab, or who are going to use bevacizumab as maintenance, are not eligible to join the study.
• • 16. Use of other investigational drugs within 28 days or at least 5 half-lives (whichever is longer) before study drug administration is not allowed.
• • 17. Patients who are pregnant or breastfeeding are excluded.
• • 18. Patients must not have either platelet or red blood cell transfusion, or granulocyte colony stimulating factor (G-CSF) within 2 weeks of the first dose of study treatment.
• • 19. Patients must not plan to donate blood during the study or for 90 days after the last dose of study treatment.
• • 20. Patients with major operation within 28 days or open biopsy within 7 days before enrolment are not eligible.
• • 21. Patients planned to have major surgery during the course of the study are excluded.