Study on the Effectiveness and Safety of Cyclophosphamide Monohydrate and Drug Combination for Patients with Persistent or Recurrent Rare Epithelial Ovarian Tumors

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What is this study about?

This clinical trial is focused on studying treatments for persistent or recurrent rare epithelial ovarian tumors. These are specific types of ovarian cancer that have returned or continued despite treatment. The study aims to evaluate the effectiveness and safety of various treatments that are guided by specific biological markers, which are unique characteristics found in the cancer cells. The treatments being tested include several medications: Endoxan (containing cyclophosphamide monohydrate), Inavolisib (also known as GDC-0077), Giredestrant (also known as GDC-9545), Cotellic (containing cobimetinib), Ipatasertib, Lynparza (containing olaparib), Paclitaxel, Verzenios (containing abemaciclib), Kadcyla (containing trastuzumab emtansine), Avastin (containing bevacizumab), and Tecentriq (containing atezolizumab). Some participants may receive a placebo, which is a substance with no active medication.

The purpose of the study is to determine how well these treatments work in shrinking or controlling the tumors, as well as to assess their safety. Participants will receive one of the treatments based on the specific characteristics of their cancer. The study will monitor the response of the tumors to the treatment and any side effects experienced by the participants. The study is designed to last for a certain period, during which participants will have regular check-ups and tests to track their progress.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on how the treatments affect their cancer. The results of this study will help in understanding which treatments are most effective for these rare types of ovarian cancer and could lead to better treatment options in the future.

1 joining the study

Upon joining the study, participation begins with an initial assessment to confirm eligibility. This includes a review of medical history and current health status.

A representative tumor specimen is required for testing to determine the appropriate treatment group.

2 treatment assignment

Based on the results of the tumor specimen testing, assignment to a specific treatment group occurs. Each group receives a different combination of medications tailored to the specific characteristics of the tumor.

3 medication administration

The treatment involves various medications, which may include oral tablets or intravenous infusions. The specific medications and their administration routes are determined by the assigned treatment group.

Medications such as cyclophosphamide monohydrate, inavolisib, giredestrant, cobimetinib, ipatasertib, olaparib, paclitaxel, letrozole, abemaciclib, trastuzumab emtansine, palbociclib, bevacizumab, and atezolizumab are used in various combinations.

The dosage, frequency, and duration of each medication depend on the specific treatment protocol.

4 monitoring and evaluation

Regular monitoring of health status and response to treatment is conducted. This includes physical examinations, imaging tests, and laboratory tests.

The primary goal is to evaluate the effectiveness of the treatment based on the objective response rate, as well as to monitor for any adverse effects.

5 completion of treatment

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

Long-term follow-up may be necessary to monitor health status and any potential late effects of the treatment.

Who Can Join the Study?

  • The patient must have persistent or recurrent epithelial ovarian cancer. This means the cancer has either not gone away or has come back after treatment.
  • The cancer must be one of the following types: low-grade serous ovarian cancer, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, mesonephric-like adenocarcinoma, or small cell carcinoma of the ovary, hypercalcemic type. It should not be a primary gastrointestinal carcinoma.
  • The disease should not be treatable with surgery that can cure it.
  • The patient must have measurable disease. This means there is at least one tumor that can be measured to see if it changes in size during the study.
  • The patient should have had previous treatment with one to four different therapies, and at least one of these treatments must have included a platinum-based drug. Hormonal therapy is not counted as one of these treatments.
  • The patient must have platinum-resistant disease, which means the cancer got worse during or within 6 months after the last platinum treatment. However, patients whose cancer did not respond at all to the first platinum treatment are not eligible.
  • A sample of the patient’s tumor must be available for special tests to help decide the treatment plan and for a central review by pathologists.
  • The patient must be female.

Who Cannot Join the Study?

  • Patients who are not female cannot participate in the study.
  • Patients who do not have Persistent or Recurrent Rare Epithelial Ovarian Tumors cannot participate in the study.
  • Patients who are not within the specified age range cannot participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital Universitario 12 De Octubre Madrid Spain
Ospedale San Raffaele S.r.l. Milan Italy
Fakultni Nemocnice Brno Brno Czechia
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Centre Hospitalier Saint Joseph Saint Luc Lyon France
Centre Hospitalier Universitaire De Nantes Nantes France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Centre Francois Baclesse Caen France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Hospital Universitario Virgen De La Victoria Malaga Spain
Ihcmayha Cvjats Dsfdsrunnnehdmufw L'hospitalet De Llobregat Spain
Bhyramwz Ueasrsklus Htmyurvh Clzmnj Besançon France
Fyuajgmna Plcn Lg Idpmacxvqwxia Bjstrixzp Dqt Hbfvzswt Uzjekbdsicsve Lt Pbj Madrid Spain
Kpjklzeg Emouffpjquzfokgrvrkdwjjl Hjiphmsazajsvydjl Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
15.07.2021
France France
Not recruiting
15.07.2021
Germany Germany
Not recruiting
15.07.2021
Italy Italy
Not recruiting
15.07.2021
Spain Spain
Not recruiting
15.07.2021

Trial locations

Biomarker-Driven Therapies are treatments that are selected based on specific biological markers found in a patient’s tumor. These markers can help doctors choose the most effective therapy for each individual. In this trial, the therapies are being tested for their ability to treat rare types of ovarian tumors that have either persisted or come back after initial treatment. The goal is to see how well these therapies work and how safe they are for patients.

Investigated diseases:

Persistent or Recurrent Rare Epithelial Ovarian Tumors – These are uncommon types of ovarian tumors that originate from the epithelial cells lining the ovary. They are characterized by their persistence or recurrence after initial treatment. The disease often progresses slowly, with symptoms that may include abdominal pain, bloating, and changes in bowel habits. Over time, these tumors can grow and potentially spread to nearby tissues or organs. The progression of the disease can vary significantly among individuals, with some experiencing more aggressive growth than others. Monitoring and management are crucial to understanding the disease’s behavior and impact on the body.

Trial ID:
2023-508194-89-00
Protocol code:
WO42178
Trial Phase:
Therapeutic exploratory (Phase II)

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