CLINICAL TRIAL

Bevacizumab for Ovary Cancer

Waitlist Available · 18+ · Female · Westwood, KS

This study is evaluating whether a drug called niraparib can improve survival in people with ovarian cancer.

See full description

About the trial for Ovary Cancer

Eligible Conditions
Ovarian Neoplasms · Carcinoma, Ovarian Epithelial

Treatment Groups

This trial involves 2 different treatments. Bevacizumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Bevacizumab
BIOLOGICAL
Niraparib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Niraparib
FDA approved

Eligibility

This trial is for female patients aged 18 and older. You must have received newly diagnosed for Ovary Cancer or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Platinum-based regimens must have consisted of at least 6 and no more than 9 treatment cycles show original
The participant must have either a normal CA-125 level or a CA-125 decrease by more than 90% during front-line therapy that is stable for at least 7 days (i.e., no increase > 15% from nadir). show original
You must have a good organ function to participate. show original
Participants with an ECOG score of zero or one are eligible. show original
People who want to participate in the study must have ovarian cancer that is at the International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB to IV stage and have recently had surgery to remove the cancer. show original
People with high-grade serous or endometrioid ovarian cancer, regardless of HRD or gBRCA mutation status, are eligible to participate show original
The participant must have had at least one attempt at optimal debulking surgery. show original
IV, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed show original
People who have received at least 3 cycles of bevacizumab chemotherapy, in combination with the last 3 cycles of platinum-based chemotherapy, are eligible to participate in this study show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Upto 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Upto 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Bevacizumab will improve 2 primary outcomes and 30 secondary outcomes in patients with Ovary Cancer. Measurement will happen over the course of At 18 months.

Progression free survival (PFS) rate
AT 18 MONTHS
PFS is defined as the proportion of participants who have not progressed or died within 18 months after niraparib combined with bevacizumab treatment initiation. Progression will be assessed by response evaluation criteria in solid tumors version 1.1 (RECIST) v1.1 criteria per Investigator assessment.
Progression Free Survival (PFS) Rate
AT 18 MONTHS
PFS rate at 18 months is defined as the percentage of participants who have not progressed or died within 18 months after niraparib combined with bevacizumab treatment initiation. Progression was assessed by response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria per Investigator assessment and defined as a 20 percent (%) increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions. Survival rate is the percentage of participants without progression assessed by RECIST v1.1 or death by the landmark timepoint. Confidence intervals was constructed using exact method.
Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs)
UP TO A MAXIMUM OF 33.68 MONTHS
TEAE is defined as any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with non-serious TEAEs with 5% threshold are reported.
Number of Participants With TEAEs Leading to Niraparib Dose Reductions
UP TO A MAXIMUM OF 33.68 MONTHS
TEAE is defined as any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAES leading to Niraparib dose reductions are reported.
Number of Participants With TEAEs Leading to Niraparib Treatment Discontinuation
UP TO A MAXIMUM OF 33.68 MONTHS
TEAE is defined as any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs leading to Niraparib treatment discontinuation are reported.
Change from Baseline in International normalized ratio
BASELINE AND UPTO 3 YEARS.
Blood samples will be collected for assessment of International normalized ratio.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can ovary cancer be cured?

The data presented on this specific topic are limited but do show that chemotherapy for ovary cancer can be effective, although the prognostic significance of the disease at presentation is poor. Data from a recent study of other studies may indicate that, with modern chemotherapy, the disease can be controlled, and the survival of cancer patients is significantly increased.

Anonymous Patient Answer

What causes ovary cancer?

Ovarian carcinomas are a type of cancer that can arise in many parts of the body and pose serious health risks. They are often caused by the gradual accumulation of multiple genetic abnormalities over many years or by unknown causes. Women affected by this disease have many different signs and symptoms which change throughout their lives. If left untreated, ovarian cancers can grow and invade many parts of the body and cause a decrease in quality of life and life expectancy. It is important that they find as early a diagnosis as they can as soon as they can.

Anonymous Patient Answer

What are the signs of ovary cancer?

The most common symptoms of [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer) are persistent, non-specific abdominal conditions such as chronic diarrhea and nausea. Ovary cancer may manifest itself as the presenting symptom of an abdominal mass (particularly a malignant tumor such as ovarian carcinoma, but also a non-cancerous condition such as a fatty mass). The most-common symptoms of ovarian cancer in women are pelvic pain, bloating, pelvic mass or swelling. Other major signs are tiredness, weight loss, or swelling of the face or in the neck, which may occur due to a recurrence of cancer, or due to metastasis to the cervical lymph nodes, and should result in prompt medical treatment.

Anonymous Patient Answer

What is ovary cancer?

Endometrium (the inner lining of the uterus) is the single most common site of [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer) (85%) in postmenopausal women. Ovarian cancer typically presents in middle-aged women and is diagnosed in 10% of all gynaecological cancers with an increased incidence of ovarian carcinoma (about 1%) every 20 to 50 years. The prognosis of ovarian cancer is often poor. Ovarian cancer is estimated to have a 5 year survival rate of less than 25%, although survival rates have improved since the introduction of chemotherapy regimens in the 1950s. In this article, ovarian cancer will be treated in reference to its various histological subtypes, location, stage, treatment modality, and prognosis.

Anonymous Patient Answer

How many people get ovary cancer a year in the United States?

Ovary cancer is more common among younger women than the American Cancer Society or the National Cancer Institute estimates. The incidence of ovarian cancer increased as age increased. Findings from a recent study, about half of the women who developed ovarian cancer had been under 45 years of age.

Anonymous Patient Answer

What are common treatments for ovary cancer?

Standard treatments for [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer) include surgery, chemotherapy, radiotherapy, and fertility removal. While surgery is a common part of ovarian cancer treatments, its role in overall cancer-free survival is limited. In addition, many chemotherapy regimens have long, painful cycles. Radiation therapy and fertility removal are not usually part of treatment unless there has been metastasis, cancer of a solid organ (cancer in the pleura, lung, brain, bones, liver, kidney, or other major organs), or recurrent ovarian cancer. One of the best treatment options is to combine surgery with standard chemotherapy for the treatment of ovarian cancer. [More about this treatment option can be found here: Ovarian cancer and adjuvant chemotherapy(https://www.ncbi.

Anonymous Patient Answer

What is the survival rate for ovary cancer?

Ovary cancer patients with synchronous and/or metastatic ovarian cancer have a high mortality rate. There was no survival advantage seen using chemotherapy for patients with early stage disease. Patients with advanced stage disease have a higher mortality rate compared with patients with early stage disease. Although a more aggressive approach should improve survival, patients might not benefit from this approach if they are candidates for more complex surgery and adjuvant chemotherapy, the current standard of care.

Anonymous Patient Answer

What is the primary cause of ovary cancer?

Female fertility-associated agents that have long been suspected of driving high rates of [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer) also do so in the presence of an increased level of cancer. The most likely explanation for this is a high cancer burden resulting from long-term exposure to ovarian hormones. Thus, the relative risks of ovarian cancer associated with fertility-related factors are significantly higher in the presence of a high cancer burden, compared with their respective values when there is a low level of cancer. This may explain why ovarian cancer is among the most common malignancies of reproductive-aged women globally.

Anonymous Patient Answer

Who should consider clinical trials for ovary cancer?

Patient interest and willingness to participate in clinical trials of ovary cancer therapies are related to patient characteristics. Age and education were associated with [participation and willingness to participate of eligible patients in clinical trials of ovarian cancer treatments(http://www.clinicaltrials.gov/ct2/show/NCT01513990)].

Anonymous Patient Answer

Has niraparib proven to be more effective than a placebo?

Niraparib treatment was well tolerated in this phase III study. No increased risk of grade 3/4 haematologic toxicity was seen with treatment. Although treatment-related adverse events included nausea and fatigue, there were not enough complete responders to report with certainty. Data from a recent study were similar to that for those previously reported and there were no clear differences in either overall ORR, PFS or OS.

Anonymous Patient Answer

What is the average age someone gets ovary cancer?

Approximately 27,000 new cases of ovarian cancer are diagnosed in the US every year. Overall, people with ovarian cancer typically have a 5 year survival rate of 75%. This is less than that of breast cancer, which is an aggressive disease with lower survival rates. Overall, about 25,000 women die of ovarian cancer each year. The average age of menopausal onset is about age 50 in industrialized countries.\n\n- Ovarian cancer"

Anonymous Patient Answer

How serious can ovary cancer be?

In a recent study, findings did not find an association between BMI and stage, grade of disease, or outcome at staging examinations in patients with stage I to III ovarian cancer. Because patients should be treated as equals, with an equal level of care for all patients, and regardless of their BMI, we do not believe that patients should be prohibited from surgery if their health permits (including BMI).

Anonymous Patient Answer
See if you qualify for this trial
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