Study on Carboplatin, Paclitaxel, Bevacizumab, and Rucaparib for Advanced Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Patients

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What is this study about?

This clinical trial is focused on studying treatments for advanced stages of ovarian cancer, primary peritoneal cancer, and Fallopian tube cancer. The study involves several medications, including Carboplatin, Paclitaxel, Bevacizumab, and Rucaparib. Carboplatin and Paclitaxel are chemotherapy drugs, while Bevacizumab is a medication that helps prevent the growth of blood vessels that feed tumors. Rucaparib is a type of drug known as a PARP inhibitor, which helps repair damaged DNA in cancer cells, potentially stopping them from growing.

The purpose of this study is to compare the effectiveness of different combinations of these medications in patients with advanced ovarian, primary peritoneal, and Fallopian tube cancer. The study will explore how well these treatments work based on the Homologous Recombination Deficient (HRD) status of the patients, which is a specific characteristic of the cancer cells that can affect how they respond to treatment. The trial will begin with a phase to determine the safest dose of the combination of Rucaparib and Bevacizumab, followed by a phase to compare the progression-free survival of patients receiving different treatment combinations.

Participants in the study will receive one of the following treatment combinations: Carboplatin, Paclitaxel, and Bevacizumab; Carboplatin, Paclitaxel, Bevacizumab, and Rucaparib; or Carboplatin, Paclitaxel, and Rucaparib. The study will monitor the patients over time to assess how long they live without the cancer getting worse. The trial aims to provide valuable information on the best treatment options for patients with these types of cancer, based on their HRD status.

1 Phase I: Dose Escalation Study

The initial phase involves determining the maximum tolerated dose of the combination of rucaparib and bevacizumab. This phase is focused on patients with advanced ovarian cancer.

During this phase, the safety and side effects of the drug combination are closely monitored. The goal is to find the highest dose that can be given without causing severe side effects.

2 Phase II: Randomized Treatment

Patients are randomly assigned to one of three treatment groups based on their HRD status (a genetic characteristic related to DNA repair).

The treatment groups are: Carboplatin-Paclitaxel-Bevacizumab, Carboplatin-Paclitaxel-Bevacizumab-Rucaparib, and Carboplatin-Paclitaxel-Rucaparib.

3 Treatment Administration

The medications are administered as follows: Carboplatin and Paclitaxel are given through an intravenous route, while Rucaparib is taken orally in the form of film-coated tablets.

The specific dosages and frequency of administration are determined by the study protocol and the patient’s response to treatment.

4 Monitoring and Evaluation

Throughout the trial, patients undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects.

Progression-free survival, overall survival, and other health outcomes are measured to evaluate the success of the treatment.

5 Completion and Follow-up

The trial is expected to conclude by June 2026. After completing the treatment, patients may continue to be monitored for long-term effects and overall health outcomes.

Follow-up assessments may include physical exams, imaging tests, and laboratory evaluations to track the patient’s health status.

Who Can Join the Study?

Women aged 18 years or older at the time of joining the study.
Patients with newly diagnosed, confirmed high-grade serous or high-grade endometrioid ovarian cancer, primary peritoneal cancer, or Fallopian tube cancer. This includes patients with mixed types of cancer if more than 50% is high-grade. Stage III patients should have had one attempt at surgery to remove as much of the tumor as possible. Stage IV patients must have had either a biopsy or surgery to remove the tumor.
Availability of previous tumor tissue samples. If the cancer progresses, a new biopsy is optional for those willing to provide it.
An ECOG Performance Status of 0-1, which means the patient is fully active or has some symptoms but can still carry out light work.
Proper kidney and liver function, which means certain blood tests must be within specific limits. For example, total serum bilirubin should be within 1.5 times the normal limit unless the patient has a specific condition called Gilbert’s syndrome.
Proper bone marrow function, which means certain blood cell counts must be above specific levels. For example, total white blood cells should be at least 2.5 billion per liter.
Able to understand and provide written consent to participate in the study.
Women who can have children must have a negative pregnancy test within 7 days before joining the study.

Who Cannot Join the Study?

Patients who do not have advanced ovarian, primary peritoneal, or Fallopian tube cancer at stage III B-C-IV.
Patients who are not female, as the study is only for female participants.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population that the study does not include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Ospedale Mater Salutis Di Legnago	Legnago	Italy
Azienda Sanitaria Locale Di Taranto	Taranto	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Azienda Sanitaria Locale Della Provincia Di Biella	Ponderano	Italy
Hrklpqbpu Mevfjnxv Svrdiz	Milan	Italy
Izfurf Idzblppk Fvbekeekbbgix Oosrlzxibet	Rome	Italy
Iguimtub Rtsjwuqzz Pvx Lu Sspjjw Dqz Tqcsof Duoy Ajlkgsz Ieaj Snuced	Meldola	Italy
Asjldbx Ubqkh Sivmcjvxw Leohmg Dy Bgnijzy	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	04.12.2017

Trial locations

Investigated drugs:

Carboplatin is a chemotherapy medication used to treat various types of cancer, including ovarian cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

Paclitaxel is another chemotherapy drug that is used to treat different types of cancer. It helps stop the growth of cancer cells by inhibiting their ability to divide.

Bevacizumab is a targeted therapy that works by blocking a protein called VEGF. This protein helps tumors form new blood vessels, which they need to grow. By blocking VEGF, Bevacizumab can help slow or stop the growth of cancer.

Rucaparib is a type of medication known as a PARP inhibitor. It is used to treat certain types of cancer by preventing cancer cells from repairing their DNA, which can lead to their death.

Investigated diseases:

Ovarian Cancer – This is a type of cancer that begins in the ovaries, which are the reproductive glands found in women. It often goes undetected until it has spread within the pelvis and abdomen. In its advanced stages, it can cause symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits. The disease progresses as cancer cells grow and potentially spread to other parts of the body. It is categorized into different stages, with stage III and IV being more advanced, indicating that the cancer has spread beyond the ovaries. The progression of the disease can vary, with some cases advancing more rapidly than others.

Primary Peritoneal Cancer – This cancer originates in the peritoneum, a thin layer of tissue lining the abdomen. It is similar to ovarian cancer in terms of symptoms and progression. The disease can cause abdominal pain, bloating, and digestive issues as it advances. It often spreads within the abdominal cavity, affecting nearby organs. The progression can be slow or rapid, depending on various factors, including the individual’s health and the cancer’s characteristics. Like ovarian cancer, it is often diagnosed at an advanced stage due to subtle early symptoms.

Fallopian Tube Cancer – This rare cancer starts in the fallopian tubes, which connect the ovaries to the uterus. It shares similarities with ovarian cancer in terms of symptoms and progression. Early signs may include pelvic pain, unusual vaginal discharge, and abdominal discomfort. As the disease progresses, it can spread to nearby organs and tissues. The cancer is often detected at a later stage, making it more challenging to manage. The progression rate can vary, with some cases advancing more quickly than others.

Trial ID:

2024-516632-99-00

Protocol code:

MITO 25.1

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Carboplatin, Paclitaxel, Bevacizumab, and Rucaparib for Advanced Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Patients

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