Heated Chemotherapy + Niraparib for Ovarian Cancer
(HOTT Trial)
Trial Summary
What is the purpose of this trial?
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease \>1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC (Arm A) will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (Arm B) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per institutional standard (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 2-3 cycles) for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing until progression or 36 months (if no evidence of disease).
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, patients on stable doses of corticosteroids for at least 4 weeks prior to randomization can continue them, and those with controlled HIV can continue antiretroviral therapy. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Niraparib for ovarian cancer?
Niraparib has been shown to significantly extend the time patients live without their cancer getting worse (progression-free survival) in several studies, including a large phase III trial. It is effective for patients with ovarian cancer who have responded to platinum-based chemotherapy, regardless of specific genetic mutations.12345
Is the combination of heated chemotherapy and Niraparib safe for treating ovarian cancer?
Cisplatin, a component of heated chemotherapy, has been used in ovarian cancer treatment and can cause side effects like neuropathy (nerve damage) and blood-related issues such as neutropenia (low white blood cell count) and thrombocytopenia (low platelet count). Niraparib, another component, is generally well-tolerated but can also cause blood-related side effects. While these treatments have been used safely in many patients, they can have serious side effects, and their safety should be discussed with a healthcare provider.678910
How does the treatment of heated chemotherapy combined with niraparib differ from other ovarian cancer treatments?
This treatment is unique because it combines heated chemotherapy, which may enhance the effectiveness of the drugs by increasing their absorption, with niraparib, a PARP inhibitor that helps prevent cancer cells from repairing themselves. Niraparib is already used as a maintenance therapy for ovarian cancer, but combining it with heated chemotherapy could potentially offer a new approach to improve outcomes.2341112
Research Team
Oliver Zivanovic, MD
Principal Investigator
GOG Foundation
Eligibility Criteria
This trial is for patients with advanced high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer. They must have completed neoadjuvant chemotherapy and be candidates for surgery without large remaining tumors. Participants need normal organ function tests and a specific genetic test result before joining.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy
Participants receive Paclitaxel and Carboplatin every 21 days for 3-4 cycles
Interval Cytoreductive Surgery (iCRS)
Surgery performed to achieve no gross residual disease, followed by randomization to HIPEC or no HIPEC
Post-operative Chemotherapy
Participants receive additional 2-3 cycles of platinum-based combination chemotherapy
Niraparib Maintenance
Participants receive niraparib individualized dosing until progression or 36 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cisplatin (Alkylating agents)
- Niraparib (PARP Inhibitor)
Find a Clinic Near You
Who Is Running the Clinical Trial?
GOG Foundation
Lead Sponsor
GlaxoSmithKline
Industry Sponsor