Study on Bevacizumab Dose Equivalence for Patients with Ovarian, Fallopian Tube, or Peritoneal Cancer Using Bevacizumab, Olaparib, Carboplatin, and Paclitaxel

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What is this study about?

This clinical trial is focused on studying the effectiveness of different doses of the medication bevacizumab in treating patients with ovarian cancer, fallopian tube cancer, and peritoneal carcinoma. The study aims to determine if there is a difference in how long patients live without their disease getting worse when treated with either a standard dose or a lower dose of bevacizumab. Bevacizumab is a type of medication known as a monoclonal antibody, which is given through an infusion, meaning it is delivered directly into the bloodstream.

In addition to bevacizumab, other medications used in this study include olaparib, carboplatin, and paclitaxel. Olaparib is taken orally in the form of a tablet, while carboplatin and paclitaxel are given as infusions. The study will involve several groups of patients who will receive different combinations of these medications, including a placebo group. The treatment period for each patient can last up to 76 weeks, depending on the specific medications they receive.

The main goal of the study is to see if the lower dose of bevacizumab is as effective as the standard dose in preventing the progression of the disease. Throughout the study, researchers will monitor the patients’ response to the treatment and any side effects they may experience. The study will also assess the overall quality of life of the participants using standardized questionnaires. This research is important for understanding how to best use bevacizumab and other medications in treating these types of cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and recent surgical procedures.

A consent form is signed to confirm understanding and agreement to participate in the study.

2 initial treatment phase

The initial treatment involves receiving olaparib orally. The dosage and frequency are determined by the study protocol.

This phase also includes receiving carboplatin and paclitaxel through infusion. The specific dosage and schedule are outlined in the study protocol.

3 bevacizumab treatment

Participants receive bevacizumab through infusion. The study aims to compare two different doses: 15 mg and 7.5 mg.

The treatment is administered as part of the first-line therapy for ovarian cancer.

4 monitoring and evaluation

Regular monitoring is conducted to assess the response to treatment. This includes evaluating the Objective Response Rate (ORR) and Progression-Free Survival (PFS).

Participants are monitored for any adverse events or side effects throughout the study.

5 completion of treatment phase

After the completion of the treatment phase, a final evaluation is conducted to assess the overall response to the therapy.

The study aims to determine the effectiveness of the different doses of bevacizumab in treating ovarian cancer.

Who Can Join the Study?

Must be a female patient aged 18 years or older.
Have had a surgery called cytoreductive surgery within 8 weeks before joining the study. This surgery aims to remove as much of the tumor as possible.
Provide a sample of the primary tumor that has been preserved in a special way (formalin-fixed, paraffin-embedded).
Have normal liver and kidney function, which means:
- Total bilirubin levels should not be more than 1.5 times the normal limit (except for those with Gilbert’s syndrome).
- Serum transaminase levels (liver enzymes) should not be more than 2.5 times the normal limit (5 times if there are liver metastases).
- Creatinine levels should not be more than 1.5 times the normal limit.
If capable of having children, must agree to avoid pregnancy by not having heterosexual intercourse or using two effective birth control methods starting 4 weeks before treatment, during treatment, and for 6 months after the last dose.
Have normal blood pressure or controlled hypertension (systolic blood pressure ≤ 140 mmHg and/or diastolic blood pressure ≤ 90 mmHg).
If of reproductive age, must be postmenopausal or have a negative pregnancy test before the first dose of the study drug.
No medical reasons that prevent the use of certain drugs like bevacizumab, carboplatin, paclitaxel, or olaparib (for those with specific genetic mutations).
Must sign a form agreeing to participate in the study voluntarily.
Be able and willing to follow the study’s rules and requirements.
Have a test done to check for specific genetic mutations (BRCA1/2) and a condition called Homologous Recombination Deficiency (HRD) using a technique called Next-Generation Sequencing (NGS).
Have a confirmed diagnosis of advanced (stage III-IV) high-grade ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Agree not to donate eggs or preserve them during the study and for 6 months after, following specific guidelines.
Have been previously disqualified from initial surgery and instead received neoadjuvant chemotherapy due to ovarian cancer. This is chemotherapy given before surgery to shrink the tumor.
Have a general health status of 0-1 according to the ECOG classification, which measures how well a person can perform daily activities.
Have specific blood test results, including:
- Platelet count of at least 150,000 per mm³.
- Leukocyte count of at least 3,000 per µL.
- Absolute neutrophil count of at least 1,500 per µL.
- Hemoglobin level of at least 10.0 g/dL.
Have normal blood clotting tests, including:
- Activated Partial Thromboplastin Time (APTT) below 1.5 times the normal limit.
- Prothrombin Time (PT) or International Normalized Ratio (INR) below 1.5 times the normal limit.
Have shown a complete or partial response to neoadjuvant chemotherapy.
Have had delayed surgery after neoadjuvant chemotherapy, regardless of any remaining disease.
Have received 3 cycles of chemotherapy with platinum and paclitaxel, along with bevacizumab at a dose of 7.5 mg/kg body weight.

Who Cannot Join the Study?

Patients who do not have ovarian cancer, fallopian tube cancer, or peritoneal carcinoma cannot participate. These are types of cancers affecting the ovaries, fallopian tubes, or the lining of the abdomen.
Only female patients are eligible for this study. Male patients cannot participate.
Patients who are considered part of a vulnerable population are not eligible. This term generally refers to groups who may have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Mazowiecki Szpital Brodnowski Sp. z o.o.	Warsaw	Poland
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku	Bialystok	Poland
Szpital Kliniczny Im. Ks. Anny Mazowieckiej samodzielny publiczny zakład opieki zdrowotnej	Warsaw	Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Dmjnzxnbkpgs Cwdlvqa Owyzpvovn Pltyyvvlgixw I Hhedfzlsiqm	Wroclaw	Poland
Sfbpjtdl Pjducsfvj Sin z osrk	Gdynia	Poland
Ueqzluparjmyo Smeseoo Kclfqgxrj Np 2 Pvx W Shpnsywecy	Szczecin	Poland
Nibawqdu Insavbkr Orehispfv Ipv Mckgp Skpsnnhkrimacmdsluttqvyighhj Ivhnhpra Byonpjwx	Cracow	Poland
Uztyyypylfmpjs Cjsczae Kypqdsujo	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not yet recruiting	01.05.2024

Trial locations

Investigated drugs:

Bevacizumab is a medication used in this clinical trial as part of the first-line therapy for ovarian cancer. It works by inhibiting the growth of blood vessels that supply nutrients to tumors, which can help slow down or stop the growth of cancer. The study is comparing different doses of bevacizumab to see if they are equally effective in delaying the progression of ovarian cancer.

Investigated diseases:

Ovarian Cancer – Ovarian cancer is a type of cancer that begins in the ovaries, which are the female reproductive glands. It often goes undetected until it has spread within the pelvis and abdomen. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms like abdominal bloating, pelvic pain, and changes in bowel habits may occur. The disease can spread to nearby tissues and organs, making it more challenging to treat as it advances. It is typically classified by the type of cells where the cancer begins, such as epithelial tumors, which are the most common. The progression of ovarian cancer can vary, with some types growing slowly and others more rapidly.

Fallopian Tube Cancer – Fallopian tube cancer is a rare cancer that occurs in the fallopian tubes, which connect the ovaries to the uterus. It often presents with symptoms similar to ovarian cancer, such as pelvic pain and abnormal vaginal discharge. The disease may spread to nearby organs and tissues, complicating treatment efforts. It is often detected at a later stage due to the subtlety of early symptoms. The cancer can be classified based on the type of cells involved, with serous carcinoma being the most common type. The progression of fallopian tube cancer can vary, with some cases advancing more quickly than others.

Peritoneal Carcinoma – Peritoneal carcinoma is a cancer that occurs in the peritoneum, the thin layer of tissue lining the abdomen. It is similar to ovarian cancer in terms of symptoms and progression, often causing abdominal pain, bloating, and changes in bowel habits. The disease can spread to other parts of the abdomen and pelvis, making it more difficult to manage as it progresses. It is often diagnosed at an advanced stage due to the non-specific nature of early symptoms. The cancer is typically classified by the type of cells involved, with serous carcinoma being the most common. The progression of peritoneal carcinoma can vary, with some cases developing more rapidly than others.

Trial ID:

2023-509659-15-00

Protocol code:

2023/ABM/01/00015

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Bevacizumab Dose Equivalence for Patients with Ovarian, Fallopian Tube, or Peritoneal Cancer Using Bevacizumab, Olaparib, Carboplatin, and Paclitaxel

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?