Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- Finland
- France
- Germany
- Greece
- Italy
- Netherlands
- Norway
- Poland
- Romania
- Spain
Study on Adjusting Chemotherapy with Carboplatin and Paclitaxel for Patients with Poor Prognostic Ovarian Cancer
This trial is exploring a new approach to chemotherapy for patients with poor prognostic ovarian cancer. The study is being conducted in the Netherlands, France, and Italy.
Inclusion criteria: You must be an adult woman aged 18 or older with high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer at stage III or IV. You should have received 3 to 4 cycles of standard carboplatin-paclitaxel chemotherapy with a poor response, indicated by an unfavorable KELIM score of less than 1.0. Your cancer should not be suitable for complete surgical removal. You must have a performance status of 0 or 1 on the ECOG scale and adequate organ and bone marrow function.
Exclusion criteria: You cannot participate if you are male, fall outside the specified age range, belong to a vulnerable population, or if your cancer can be completely removed by surgery.
Study focus: The trial tests a new dosing schedule involving more frequent, smaller doses of chemotherapy, known as a weekly dose-dense regimen. The goal is to determine if this new approach is more effective than the standard treatment in improving outcomes such as increasing the chances of successful surgery and extending survival times.
Investigational drugs: The study uses carboplatin and paclitaxel, both standard chemotherapy drugs for ovarian cancer. Carboplatin works by interfering with the DNA of cancer cells, while paclitaxel inhibits their ability to divide. The trial also involves bevacizumab, which prevents the growth of blood vessels that supply the tumor, and filgrastim, which boosts white blood cell counts.
Study on Niraparib, Carboplatin, and Paclitaxel for Advanced Ovarian Cancer Patients After Tumor Removal
This trial is investigating the use of niraparib as maintenance therapy after chemotherapy for patients with advanced high-grade ovarian cancer. The study is taking place in Germany, Spain, Italy, Belgium, Czechia, and Austria.
Inclusion criteria: You must be a woman aged 18 or older with advanced high-grade epithelial ovarian cancer at stage III or IV. You should have undergone surgery to remove the primary tumor, with a CT scan confirming no visible tumor remains. You must have tumor samples available for special testing to confirm HRD positive status. Your general health must be good, with a performance status of 0 or 1, and you must be able to take oral medications. You need adequate organ and bone marrow function.
Exclusion criteria: You cannot participate if you have any other type of cancer not specified in the study, have not undergone surgery to remove the primary tumor, have remaining tumor mass after surgery, or are male.
Study focus: The study aims to determine if taking niraparib after three cycles of chemotherapy is as effective as taking it after six cycles. The goal is to see if the shorter treatment duration can provide similar benefits in preventing cancer from returning.
Investigational drug: Niraparib is a PARP inhibitor that works by blocking an enzyme involved in DNA repair. By preventing cancer cells from repairing their DNA, niraparib helps lead to their death. It is given as an oral tablet.
Study on Letrozole vs. Chemotherapy (Carboplatin and Paclitaxel) for Patients with Advanced Low-Grade Serous Ovarian Cancer with Hormone Receptors
This trial is comparing the effectiveness of letrozole with standard chemotherapy for patients with low-grade serous ovarian cancer that is positive for estrogen and/or progesterone receptors. The study is being conducted in Italy.
Inclusion criteria: You must be 18 years or older with newly diagnosed low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum at stage III-IV. Your cancer must show positivity for estrogen and/or progesterone receptors. You should have had surgery to remove as much of the tumor as possible and be postmenopausal. You must join the study within 90 days after surgery and have a performance status of 0-1 on the ECOG scale. You need adequate bone marrow, liver, and kidney function.
Exclusion criteria: You cannot participate if you do not have low-grade serous epithelial ovarian cancer, if your cancer is not at stage III-IV, if it is not ER+ and/or PgR+, if you have not had primary surgery, or if you are male.
Study focus: The study aims to determine if letrozole can provide a longer period without the cancer worsening compared to standard chemotherapy. Participants will be randomly assigned to receive either letrozole or chemotherapy.
Investigational drug: Letrozole is an aromatase inhibitor that works by lowering estrogen levels in the body. This can help slow down or stop the growth of cancer cells that need estrogen to grow. It is taken as an oral tablet.
Study of Niraparib and Dostarlimab Combined with Platinum Therapy for Newly Diagnosed Stage III or IV Non-mucinous Epithelial Ovarian Cancer
This trial is evaluating a combination treatment using niraparib and dostarlimab along with standard platinum-based therapy for patients with newly diagnosed Stage III or IV non-mucinous epithelial ovarian cancer. The study is available in Germany, Belgium, France, Romania, Finland, Poland, Italy, Norway, Spain, the Netherlands, Greece, Denmark, and Czechia.
Inclusion criteria: You must be a female aged 18 or older with Stage 3 or 4 non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer. You need adequate physical performance status and normal or controlled blood pressure. You must be able to take oral medications and provide blood and tumor tissue samples. You need adequate organ function, including sufficient blood cell counts, normal kidney function, and normal liver function. If able to become pregnant, you must have a negative pregnancy test and use effective contraception.
Exclusion criteria: You cannot participate if you are below 18 years old, male, have been previously treated with dostarlimab or niraparib, have a known allergy to the study medications, have mucinous ovarian cancer, have other active cancers requiring treatment, have severe heart conditions, are pregnant or breastfeeding, or have mental conditions that could interfere with following study procedures.
Study focus: The study aims to determine if adding both niraparib and dostarlimab to standard platinum-based therapy improves how long patients can live without their cancer getting worse, compared to using just niraparib with platinum-based therapy. Participants will receive regular medical check-ups to monitor their health and how well the treatment is working.
Investigational drugs: Dostarlimab is an immunotherapy medication that helps the immune system fight cancer cells by blocking a protein that cancer cells use to hide from the immune system. It is given as an intravenous infusion. Niraparib is a PARP inhibitor that works by preventing cancer cells from repairing their damaged DNA, helping to stop them from growing and spreading. It is taken as an oral capsule.
Summary
The five ongoing clinical trials for Stage IV ovarian cancer demonstrate a diverse approach to treating advanced disease. The trials are distributed across numerous European countries, with Italy, Belgium, France, Germany, and Spain hosting multiple studies. This wide geographic distribution provides access to various patient populations and treatment centers.
Several trials focus on optimizing chemotherapy regimens using carboplatin and paclitaxel, either through dose-dense schedules or by combining them with maintenance therapies. There is notable emphasis on PARP inhibitors, particularly niraparib, which appears in three of the five trials, highlighting the growing importance of this class of medications in ovarian cancer treatment.
The studies also reflect different stages of treatment, from first-line therapy to maintenance approaches after surgery. Two trials specifically target patients with poor prognostic factors, addressing an important need for improved treatment options in challenging cases. Additionally, one trial explores hormone therapy with letrozole for a specific subset of patients with hormone receptor-positive low-grade serous ovarian cancer.
Most trials require participants to have good overall health status and adequate organ function, ensuring patient safety during treatment. The inclusion of immunotherapy with dostarlimab in combination with other treatments represents an important development in exploring immune-based approaches for this disease.