CLINICAL TRIAL

Bevacizumab for Carcinoma, Ovarian Epithelial

1 Prior Treatment
Locally Advanced
Metastatic
Recurrent
Waitlist Available · 18+ · Female · Abbotsford, Canada

This study is evaluating whether a lower dose of an anti-cancer drug is as effective as a higher dose.

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About the trial for Carcinoma, Ovarian Epithelial

Eligible Conditions
Ovarian Neoplasms · Carcinoma, Ovarian Epithelial · Ovarian Cancer · Platinum-resistant Ovarian Cancer (PROC)

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
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Bevacizumab
DRUG

About The Treatment

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

Side Effect Profile for Bevacizumab

Bevacizumab
Show all side effects
22%
vitreous hemorrhage
17%
worsening of cataract
9%
vitreous syneresis
9%
posterior capsule opacification
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
4%
cranial nerve VI palsy
4%
bradycardia
0%
epiretinal membrane
0%
increased intraocular pressure
0%
congestive heart failure
0%
choroidal detachment
vitreous hemorrhage
22%
worsening of cataract
17%
vitreous syneresis
9%
posterior capsule opacification
9%
pneumonia
4%
pyelonephritis
4%
colon cancer
4%
cranial nerve VI palsy
4%
bradycardia
4%
epiretinal membrane
0%
increased intraocular pressure
0%
congestive heart failure
0%
choroidal detachment
0%
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02036424) in the Bevacizumab ARM group. Side effects include: vitreous hemorrhage with 22%, worsening of cataract with 17%, vitreous syneresis with 9%, posterior capsule opacification with 9%, pneumonia with 4%.

Eligibility

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Carcinoma, Ovarian Epithelial or one of the other 3 conditions 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:
The presence of clinically and/or radiologically documented disease must be confirmed by radiology studies that are performed within 28 days of randomization. show original
The CT scan showed a lesion with a longest diameter of more than 10 mm. show original
This disease doesn't respond to platinum-based treatments, and patients tend to progress within six months of completing a platinum-containing protocol. show original
The patient's physical exam found lymph nodes that were 10 mm in size, while a CT scan found lymph nodes that were 15 mm in size. show original
Patients must be at least 18 years old. show original
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. show original
The study allows for any number of prior lines of treatment, but all patients must have at least one prior chemotherapy regimen that includes platinum show original
The patient has a histologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal, or fallopian tube carcinoma, which is classified as advanced/metastatic/recurrent or unresectable, and for which no curative therapy exists. show original
Chest x-ray appears to be more than 20 mm. show original
People taking part in the study must have never received an anti-angiogenesis inhibitor including bevacizumab. show original
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: through study completion, up to 4 years
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, up to 4 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: through study completion, up to 4 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 1 primary outcome and 5 secondary outcomes in patients with Carcinoma, Ovarian Epithelial. Measurement will happen over the course of From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years months.

progression-free survival
FROM DATE OF RANDOMIZATION UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 4 YEARS MONTHS
duration of time from registration to time progression
FROM DATE OF RANDOMIZATION UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 4 YEARS MONTHS
Compare treatment-emergent grade 3-5 AEs
4 MONTHS AFTER LAST DOSE
Compare treatment-emergent grade 3-5 AEs
4 MONTHS AFTER LAST DOSE
Quality of Life changes
DURING TREATMENT AND 4 WEEKS AFTER COMING OFF TREATMENT
Quality of Life changes
DURING TREATMENT AND 4 WEEKS AFTER COMING OFF TREATMENT
Duration of response
FROM TIME OF OBJECTIVE RESPONSE UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 4 YEARS MONTHS
Duration of response
FROM TIME OF OBJECTIVE RESPONSE UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 4 YEARS MONTHS
Overall survival
FROM DATE OF RANDOMIZATION UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 4 YEARS MONTHS
duration of time from registration to time of death from any cause.
FROM DATE OF RANDOMIZATION UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 4 YEARS MONTHS
Estimate drug cost savings
THROUGH STUDY COMPLETION, UP TO 4 YEARS
Estimate drug cost savings
THROUGH STUDY COMPLETION, UP TO 4 YEARS

Who is running the study

Principal Investigator
J. K.
Jenny Ko, Medical Oncologist
British Columbia Cancer Agency

Patient Q & A Section

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

What is the primary cause of carcinoma, ovarian epithelial?

Carcinoma, ovarian epithelial, occurs in women of all races and with all age groups. The most common primary site is the ovary, but carcinoma, ovarian epithelial, also occurs in the fallopian tubes, peritoneum, adrenal gland, uterus, and intestine.

Anonymous Patient Answer

What is carcinoma, ovarian epithelial?

Ovarian carcinoma consists of tumors derived from the ovarian theca (endothelial) layer. In about 90% of cases, the tumor is solid and tends to metastasize to distant sites rather than regional lymph nodes. The overall 5-year survival was 38%. Epithelial serous and endometrioid tumors have significantly better survival to the time of disease recurrence compared to clear cell tumors, however this finding is dependent on the stage and response rates of cancer.

Anonymous Patient Answer

Can carcinoma, ovarian epithelial be cured?

We can summarize our findings as follows: (1) the primary tumor remains an incurable disease, (2) the initial, curative treatment is a surgery without adjuvant chemotherapy, (3) recurrence of the tumor after surgery is rare, and (4) ovarian epithelial cancer is not a curable disease.

Anonymous Patient Answer

What causes carcinoma, ovarian epithelial?

Data from a recent study reinforces the hypothesis that ovarian carcinoma has one primary site of origin, and that this origin is not associated with smoking or ovarian cysts. Ovarian carcinoma, especially its serous phenotype, occurs at an increased rate in women over the age of 45 years.

Anonymous Patient Answer

What are common treatments for carcinoma, ovarian epithelial?

Chemotherapy is widely used, particularly in recurrent carcinoma. Tissue preservation and cytoreductive surgery are not a common treatment, with the main focus being on minimizing the impact of the cancer. Radiation therapy is rarely involved, except in the treatment of recurrent disease.

Anonymous Patient Answer

What are the signs of carcinoma, ovarian epithelial?

The symptoms of carcinoma, ovarian epithelial are diverse. Ovarian carcinoma often presents as abdominal pain because it produces large amounts of CA-125. However, this does not always occur due to other causes and the presence of pain and CA-125 levels should be obtained cautiously before deciding surgery is needed. The presence of CA-125 with a palpable lesion is one of the highest risk factors for ovarian neoplasia.

Anonymous Patient Answer

How many people get carcinoma, ovarian epithelial a year in the United States?

About 1110,000 cases of carcinoma are diagnosed each year in the United States. This makes it the most common cancer in American women. It is seen in all age and socioeconomic groups equally.

Anonymous Patient Answer

Does bevacizumab improve quality of life for those with carcinoma, ovarian epithelial?

In a recent study, findings suggests that bevacizumab improves both QOL and QLQ-CX items for patients with carcinoma, ovarian epithelial compared to those without bevacizumab. In a recent study, findings suggest that bevacizumab treatment might improve QOL in patients with carcinoma, ovarian epithelial.

Anonymous Patient Answer

How quickly does carcinoma, ovarian epithelial spread?

Patients with carcinoma are more likely to have lymphatic and hematogenous spread in the ovarian epithelial component compared to patients with ovarian stromal sarcoma. The incidence of lymphatic, and hematogenous spread increases in the presence of a component of ovarian epithelial sarcoma and in the presence of nodal or distant metastases.

Anonymous Patient Answer

Who should consider clinical trials for carcinoma, ovarian epithelial?

There are no clear recommendations to facilitate informed, evidence-based decisions regarding clinical trials for carcinoma, ovarian epithelia. We should consider patients in the age of 40-80 years, women in the age of 55 years with FIGO stage 1-2 of high grade non-epithelial malignancy and BRCA carriers.

Anonymous Patient Answer

Does carcinoma, ovarian epithelial run in families?

We concluded that carcinoma, ovarian epithelial and/or cancer of other origin may be hereditary and thus are candidates for genetic investigations of hereditary breast/ovarian cancer syndromes.

Anonymous Patient Answer

What is the average age someone gets carcinoma, ovarian epithelial?

The mean age was 59.3 yr (SD 15 yr.)<br>About half of these patients were symptomatic. About 9% died before or during surgery. About 1 in 25 were diagnosed with multiple masses.<br>The 5 yr. Survival rate was 67%. Survivors included those without the BRCA1 mutation but with other defects in DNA repair genes.

Anonymous Patient Answer
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