In short
This article provides information about 2 ongoing clinical trials focused on peritoneal sarcoma and related cancers. These studies are testing new treatment approaches, including adjusted chemotherapy schedules and targeted medications, in patients whose cancer has not responded well to standard treatment. Trials are currently taking place in France, Italy, and the Netherlands.
Clinical trial locations
- France
- Italy
- Netherlands
Study on Adjusting Chemotherapy with Carboplatin and Paclitaxel for Patients with Poor Prognostic Ovarian Cancer
This trial is investigating whether changing the timing and frequency of chemotherapy can improve outcomes for patients with advanced ovarian, primary peritoneal, or fallopian tube cancer that has not responded well to initial treatment. The study compares a standard treatment schedule, where larger doses of chemotherapy are given every three weeks, with a new approach called a weekly dose-dense regimen, where smaller doses are given more frequently.
Main inclusion criteria: This study is looking for adult women aged 18 or older who have been diagnosed with high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. Participants must have advanced disease at stage III or IV and must have already received 3 to 4 cycles of standard carboplatin-paclitaxel chemotherapy. To qualify, patients need to show a poor response to this initial treatment, measured by a KELIM score of less than 1.0, which indicates low chemosensitivity. The cancer should not be suitable for complete surgical removal. Participants must also have adequate organ and bone marrow function and be able to carry out light activities with an ECOG performance status of 0 or 1.
Main exclusion criteria: The trial excludes patients whose cancer responds well to chemotherapy or can be completely removed by surgery. It also excludes male patients and those with a favorable KELIM score of 1.0 or higher. Vulnerable populations requiring special protection are not eligible for this study.
Focus and goals: The main goal is to determine whether the weekly dose-dense treatment schedule is more effective than standard treatment in patients with poor prognostic factors. Researchers will monitor how long the cancer stays under control without getting worse, called progression-free survival, as well as overall survival. The study also tracks the overall response to treatment, quality of life, and any side effects experienced during treatment. Findings from this study could help develop better treatment strategies for patients with challenging cases of ovarian and peritoneal cancer.
Investigational drugs: The trial uses carboplatin and paclitaxel, two well-established chemotherapy medications commonly used to treat ovarian cancer. Carboplatin works by interfering with the DNA of cancer cells, preventing them from growing and dividing. Paclitaxel helps stop cancer cell growth by inhibiting their ability to divide. The trial tests whether giving these medications on a weekly schedule, rather than the standard three-week schedule, can improve outcomes. Additional medications used include bevacizumab, which helps prevent the growth of blood vessels that supply tumors, and filgrastim, which supports white blood cell production during chemotherapy.
Study of Mirvetuximab Soravtansine compared to standard chemotherapy in women with platinum-resistant advanced ovarian cancer with high folate receptor expression
This study examines whether a targeted medication called mirvetuximab soravtansine works better than standard chemotherapy in treating patients with platinum-resistant advanced ovarian, peritoneal, or fallopian tube cancer. The trial specifically focuses on cancers that show high levels of a protein called folate receptor-alpha on their surface.
Main inclusion criteria: This study is open to women aged 18 or older who have high-grade ovarian, peritoneal, or fallopian tube cancer that has become resistant to platinum-based chemotherapy within 6 months after treatment. Participants must have received between 1 and 3 previous cancer treatments and their tumors must test positive for high levels of folate receptor-alpha. Patients need to have at least one tumor that can be measured on scans and must show adequate blood counts, liver function, and kidney function. They must be able to perform daily activities with minimal assistance, having an ECOG performance status of 0 or 1. Participants must also wait an appropriate time after previous treatments before joining this study.
Main exclusion criteria: The trial excludes patients who have previously been treated with mirvetuximab soravtansine or any other folate receptor-targeted therapy. Patients with active or untreated brain metastases, serious heart conditions, severe infections, severe liver or kidney problems, or a history of other cancers within the past 3 years are not eligible. The study also excludes women who are pregnant or breastfeeding, or those unable to use effective birth control during the study period.
Focus and goals: The primary objective is to compare how long patients live without their cancer getting worse when treated with mirvetuximab soravtansine versus standard chemotherapy. Researchers will also evaluate how well patients respond to treatment, overall survival time, quality of life with particular focus on abdominal symptoms, and any side effects that occur. The study aims to determine whether targeted therapy offers advantages over conventional chemotherapy for this specific group of patients.
Investigational drugs: The main medication being tested is mirvetuximab soravtansine, a targeted therapy that specifically seeks out and attaches to cancer cells with high levels of folate receptor-alpha on their surface. This medication is designed to deliver anti-cancer agents directly to tumor cells while minimizing damage to healthy cells. It combines a folate receptor-binding antibody with a powerful anti-cancer agent called soravtansine. The comparison group receives standard chemotherapy chosen by the doctor from options including topotecan, paclitaxel, or doxorubicin. Both treatments are given through intravenous infusion, but they work in fundamentally different ways: mirvetuximab soravtansine targets specific cancer cells, while standard chemotherapy affects all rapidly dividing cells in the body.
Summary
Two clinical trials are currently recruiting patients with peritoneal and related gynecological cancers. Both studies focus on patients with difficult-to-treat disease: those who have not responded well to standard platinum-based chemotherapy or whose cancer has become resistant to it. One trial explores whether adjusting the schedule of existing chemotherapy drugs can improve outcomes, while the other tests a newer targeted therapy approach.
The first trial is being conducted across three European countries, including France, Italy, and the Netherlands, reflecting a collaborative international effort. The second trial is currently limited to France. Both studies are designed to help improve treatment options for patients facing challenging prognoses, with careful monitoring of both effectiveness and side effects. The trials emphasize the importance of patient selection based on specific disease characteristics, such as chemosensitivity scores and folate receptor expression levels.
