Ongoing Clinical Trials for Peritoneal Carcinoma Metastatic
This article provides information about ongoing clinical trials for peritoneal carcinoma metastatic, a serious condition where cancer has spread to the peritoneum, the tissue lining the abdomen. Currently, there is 1 clinical trial being conducted across multiple countries, testing a new targeted treatment called farletuzumab ecteribulin in comparison to standard chemotherapy options. (Also known as: Metastatic peritoneal carcinoma, Secondary peritoneal cancer).
Clinical trial locations
- Belgium
- Italy
- Spain
Study of Farletuzumab Ecteribulin vs. Chemotherapy for Women with Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This clinical trial is testing a new treatment approach for women diagnosed with platinum-resistant high-grade serous cancer affecting the ovaries, peritoneum, or fallopian tubes. The cancer being studied has shown resistance to platinum-based chemotherapy, which is typically a standard treatment for these types of cancer. The trial compares the investigational drug farletuzumab ecteribulin (also known as MORAb-202) with standard chemotherapy options selected by the treating physician.
Main inclusion criteria:
- Women aged 18 years or older who can provide informed consent
- Confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer through tissue testing
- Cancer that is platinum-resistant, meaning it has returned within 1 to 6 months after completing platinum-based treatment
- Prior treatment with 1 to 3 previous lines of systemic therapy, with participants being suitable for single-drug treatment
- Previous treatment with bevacizumab (a targeted cancer drug), or unable to receive it for medical reasons, or refused or couldn’t access it
- Cancer progression confirmed by RECIST v1.1 criteria with at least one measurable tumor
- Available cancer tissue sample for folate receptor alpha testing
- Good overall health status with an ECOG performance status of 0 or 1, meaning participants can carry out daily activities with little to no restriction
Main exclusion criteria:
- Having a different type of cancer than those being studied
- Being part of a vulnerable population requiring special protection
- Having received certain treatments or medications that could interfere with the study
- Having other serious health conditions that could affect safety or study results
- Being unable to follow study procedures or attend required visits
Focus and goal: The trial aims to evaluate how well farletuzumab ecteribulin works compared to standard chemotherapy options. Participants are randomly assigned to receive either the new antibody-drug conjugate treatment or one of the standard chemotherapy options, which may include drugs like Caelyx (doxorubicin hydrochloride), paclitaxel, or topotecan. All medications are given through intravenous infusion directly into the bloodstream. The study monitors participants closely to assess treatment response, measure how long the response lasts, and track any side effects. The primary goal is to determine the objective response rate and safety profile of MORAb-202.
Investigational drug: Farletuzumab ecteribulin (MORAb-202) is an antibody-drug conjugate designed to target cancer cells more precisely. It combines an antibody that specifically recognizes folate receptor alpha, a protein often found on the surface of certain cancer cells, with a drug that can destroy these cells. This targeted approach aims to deliver treatment directly to the cancer cells while minimizing damage to healthy tissue. The comparator treatments are standard chemotherapy options chosen by the investigator based on the participant’s individual needs.
Throughout the trial, participants undergo several steps including eligibility confirmation, randomization to treatment groups, treatment administration, regular monitoring and evaluation for response and side effects, and ongoing follow-up visits to assess long-term outcomes. Healthcare professionals closely supervise all participants to ensure their well-being and collect important information about the treatment’s effectiveness and safety.
Summary
Currently, there is one clinical trial available for patients with peritoneal carcinoma metastatic, specifically focusing on platinum-resistant high-grade serous cancers affecting the ovaries, peritoneum, or fallopian tubes. This trial is being conducted in three European countries: Belgium, Italy, and Spain. The study represents an important research effort to find more effective treatments for patients whose cancer has not responded well to platinum-based chemotherapy.
The trial focuses on testing farletuzumab ecteribulin, a novel antibody-drug conjugate that targets folate receptor alpha on cancer cells. This targeted approach represents a newer strategy in cancer treatment compared to traditional chemotherapy. The study design allows for direct comparison between this investigational drug and established chemotherapy options, which will help determine whether the new treatment offers advantages in terms of effectiveness and safety.
For patients considering participation, it’s important to note that eligibility requires previous treatment with platinum-based chemotherapy and bevacizumab (or valid reasons for not having received it), as well as good overall health status. The trial provides access to a potentially promising new treatment option for those with limited alternatives due to platinum resistance.
