Study Comparing Paclitaxel, Carboplatin, and Oregovomab with Paclitaxel, Carboplatin, and Placebo for Patients with Advanced Ovarian Cancer

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What is this study about?

This clinical trial is focused on studying treatments for advanced epithelial ovarian cancer, which can also affect the fallopian tubes or the peritoneum. The study is comparing two treatment approaches for patients who have recently been diagnosed with these conditions. One group of patients will receive a combination of chemotherapy drugs called paclitaxel and carboplatin along with a new treatment called Oregovomab. The other group will receive the same chemotherapy drugs but with a placebo instead of Oregovomab. The purpose of the study is to see if adding Oregovomab to the standard chemotherapy can help patients live longer without their cancer getting worse.

Participants in the study will receive their treatments through an infusion, which means the medication is given directly into a vein. The study will follow patients over a period of time to monitor their health and the progression of their cancer. The main goal is to determine if the addition of Oregovomab can improve the time patients live without their cancer progressing, which is known as progression-free survival. The study will also look at overall survival, which is the length of time patients live after starting the treatment, and any side effects that may occur.

This trial is designed to provide important information about the potential benefits of Oregovomab when used alongside standard chemotherapy for patients with advanced ovarian cancer. By comparing the two groups, researchers hope to find out if this new treatment can offer better outcomes for patients facing these challenging conditions.

1 Joining the study

Upon joining the study, participation is confirmed through a signed informed consent form. This form allows the release of personal health information necessary for the study.

2 Initial treatment phase

The treatment involves chemotherapy with paclitaxel and carboplatin. Paclitaxel is administered at a dose of 175 mg per square meter of body surface area, given intravenously every 3 weeks for 6 cycles. Carboplatin is given with an area under the curve (AUC) of 6, also intravenously every 3 weeks.

For those who have undergone primary debulking surgery, the first cycle of chemotherapy, with or without oregovomab or placebo, is expected to start within 6 weeks after surgery.

3 Interval debulking surgery

For participants undergoing interval debulking surgery, neoadjuvant treatment with 3 cycles of paclitaxel and carboplatin is required before surgery. Paclitaxel is initially given at 175 mg per square meter, and carboplatin at AUC 5-6, both intravenously every 3 weeks.

After surgery, participants continue with paclitaxel and carboplatin every 3 weeks starting from cycle 4, with or without oregovomab or placebo, within 6 weeks post-surgery.

4 Ongoing treatment and monitoring

Throughout the study, regular monitoring of health status and response to treatment is conducted. This includes assessments of progression-free survival and overall survival, as well as monitoring for any adverse events.

Participants are required to complete quality of life questionnaires to assess the impact of treatment on daily living.

5 Completion of study participation

The study is estimated to conclude by August 26, 2027. Participants will continue to be monitored until the end of the study or until they choose to withdraw from the study.

Who Can Join the Study?

Must be an adult, 18 years old or older.
Must have adequate kidney function, meaning the creatinine level should be no more than 1.5 times the normal limit.
Must have an ECOG Performance Status of 0 or 1, which means the person is fully active or has some symptoms but can still do light work.
Women who can have children must agree to use a very effective form of birth control from the start of the study treatment until 6 months after the last dose.
Must sign a consent form agreeing to participate and allow access to personal health information.
Must be willing and able to fill out questionnaires about their quality of life.
Must have a new diagnosis of epithelial adenocarcinoma of the ovary, fallopian tube, or peritoneum at FIGO Stage III or IV, which are advanced stages of cancer.
Must have one of the eligible types of cancer cells, such as high-grade serous adenocarcinoma or clear cell adenocarcinoma.
Must have completed debulking surgery, which is a surgery to remove as much of the tumor as possible. This can be either primary or interval debulking surgery.
Must have suitable veins for the procedures required in the study.
Must have CA 125 levels of at least 50 U/mL, which is a marker used to assess ovarian cancer.
Must have adequate bone marrow function, meaning a certain level of white blood cells and platelets.
Must have a hemoglobin level of at least 8.0 g/dL, which is a measure of red blood cells. Blood transfusions are allowed up to 48 hours before the first dose of treatment.
Must have adequate liver function, meaning certain liver enzymes and bilirubin should be within specified limits.

Who Cannot Join the Study?

Patients who have not been diagnosed with advanced epithelial ovarian, fallopian tube, or peritoneal carcinoma cannot participate. This means the study is only for those with these specific types of cancer.
Patients who have not undergone optimal debulking surgery are excluded. This surgery involves removing as much of the tumor as possible.
Patients who are not newly diagnosed with ovarian cancer at FIGO Stage III or IV are excluded. FIGO stages describe the extent of cancer spread, with Stage III and IV being more advanced.
Only female patients can participate, so male patients are excluded.
Patients who are part of a vulnerable population may be excluded. This refers to groups who might need special protection in research, like children or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Fakultni Nemocnice Bulovka	Prague	Czechia
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
University Of Debrecen	Debrecen	Hungary
Hospital Clinic De Barcelona	Barcelona	Spain
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Gasthuiszusters Antwerpen	Antwerp	Belgium
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Hungary
CHC MontLegia	Liege	Belgium
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Fakultní nemocnice v Motole	Prague	Czechia
Ccnohkvyv Udxbckbkyzrmoe Sxkoiouao	Woluwe-Saint-Lambert	Belgium
Ipvvrfvy Caaomt Duzjlpkhasltdyzqj	L'hospitalet De Llobregat	Spain
Bpriofgmdsc Vwhijccdt Oyelzibltfrh	Kecskemet	Hungary
Hjsfgraq Db Lx Sqnxt Chvr I Shta Ptm	Barcelona	Spain
Hslcxezo Vlau dlpdtilg	Barcelona	Spain
Ejriocpwqpn Ckgopvknfiybhxvqkdvxxsrxpn	Budapest	Hungary

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	16.08.2020
Czechia	Not recruiting	16.08.2020
Hungary	Not recruiting	16.08.2020
Italy	Not recruiting	16.08.2020
Spain	Not recruiting	16.08.2020

Trial locations

Investigated drugs:

Oregovomab

Paclitaxel is a type of chemotherapy medication used to treat various types of cancer, including ovarian cancer. It works by stopping cancer cells from dividing and growing, which helps to slow down or stop the spread of the cancer.

Carboplatin is another chemotherapy drug that is often used in combination with other medications to treat ovarian cancer. It works by damaging the DNA of cancer cells, which prevents them from multiplying and causes them to die.

Oregovomab is an investigational medication being studied for its potential to improve the effectiveness of chemotherapy in treating ovarian cancer. It is designed to work with the body’s immune system to help target and destroy cancer cells.

Investigated diseases:

Advanced epithelial ovarian, fallopian tube, or peritoneal carcinoma – This is a type of cancer that originates in the epithelial cells lining the ovaries, fallopian tubes, or peritoneum. It is considered advanced when it has spread beyond the ovaries to other parts of the pelvis or abdomen. The disease often progresses silently, with symptoms like abdominal bloating, pelvic pain, and changes in bowel habits appearing in later stages. As the cancer advances, it may spread to the lining of the abdomen and other organs, complicating treatment. The progression is typically monitored through imaging studies and clinical evaluations. Early detection is challenging due to the subtlety of initial symptoms.

Trial ID:

2024-519218-30-00

Protocol code:

QPT-ORE-005

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Paclitaxel, Carboplatin, and Oregovomab with Paclitaxel, Carboplatin, and Placebo for Patients with Advanced Ovarian Cancer

What is this study about?

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