Bevacizumab for Carcinoma, Ovarian Epithelial

1
Effectiveness
2
Safety
University of Texas MD Anderson Cancer Center, Houston, TX
+8 More
Bevacizumab - Drug
Eligibility
18+
Female
Eligible conditions
Carcinoma, Ovarian Epithelial

Study Summary

Bevacizumab in Ovarian Cancer Patients With Disease at Second-Look Surgery

See full description

Eligible Conditions

  • Carcinoma, Ovarian Epithelial
  • Ovary Cancer
  • Fallopian Tube Cancer
  • Cancer
  • Genital Neoplasms, Female
  • Ovarian Neoplasms
  • Malignant Neoplasms of Female Genital Organs
  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Neoplasms
  • Fallopian Tubes Cancer
  • Neoplasms

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Bevacizumab will improve 1 primary outcome in patients with Carcinoma, Ovarian Epithelial. Measurement will happen over the course of 63 days.

63 days
Progression-Free Survival (PFS) of Participants with Positive Second-Look Findings Treated with Bevacizumab

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Bevacizumab
vitreous hemorrhage
22%
worsening of cataract
17%
vitreous syneresis
9%
posterior capsule opacification
9%
pyelonephritis
4%
pneumonia
4%
colon cancer
4%
cranial nerve VI palsy
4%
bradycardia
4%
increased intraocular pressure
0%
epiretinal membrane
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%, pyelonephritis with 4%.

Trial Design

2 Treatment Groups

Control
Bevacizumab

This trial requires 35 total participants across 2 different 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.

Bevacizumab
Drug
Participants receive Bevacizumab by vein on Day 1 of every 21-day study cycle, for as long as study doctor thinks it is in participant's best interest.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 63 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 63 days for reporting.

Closest Location

University of Texas MD Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The text states that the patient has a high-grade epithelial non-mucinous ovarian, fallopian tube, or primary peritoneal cancer that has been confirmed by histology. show original
Patients who have received at least six cycles of platinum and taxane therapy are considered to have received standard of care frontline surgical and chemotherapy treatment show original
Some patients who have residual ovarian cancer after their first surgery may be eligible for a second surgery show original
We are willing to allow the use of archival tissue from both second-look surgery and primary surgery or biopsy for use in this study. show original
The person should have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale to be eligible for the study. show original
The patient must have adequate organ function as determined by the following laboratory values: a) absolute neutrophil count (ANC) >/= 1,000 /mcL; b) Platelets >/= 100,000/mcL; (c) Hgb >/= 8 g/dL; (d) Creatinine Clearance >/= 40 mL/min (measured or calculated per local practice); (e) Total Bilirubin </= 1.5 × upper limit of normal (ULN) or </= 3 × ULN in the case of suspected/documented Gilbert's Syndrome; and (f) AST (SGOT) and ALT (SGPT) </= 2.5 X ULN. show original
Signed written Informed Consent.
Must be at least 18 years old. show original
The person has undergone a second surgery by an MD Anderson Gynecologic Oncology faculty after having a complete clinical response to frontline surgery and adjuvant chemotherapy show original
After having surgery to look at her tumor again, the patient was able to start taking bevacizumab within seven weeks. show original

Patient Q&A Section

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

Does ovary cancer run in families?

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Genetic testing in families with OvCa may identify a subset of OvCa where genetic or environmental modifiers are present that may predispose to cancer. The presence of other cancers may exacerbate risk related to OvCa in this subset.

Unverified Answer

What are the signs of ovary cancer?

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Older women with a pelvic mass should have a pelvic examination before they have blood tests; it is important to not overlook cancer when a pelvic mass is found in an older woman.

Unverified Answer

What are common treatments for ovary cancer?

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The options to treat ovarian cancer in the first line setting include surgery, chemotherapy and radiation therapy. These can be provided in a neoadjuvant as well as in a salvage setting. In addition, there is an integral role for palliative care where patients and their family need to understand the options and the risks of ovarian cancer.

Unverified Answer

Can ovary cancer be cured?

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Data from a recent study are hopeful, but the long-term prognosis is guarded. Further studies with a longer follow-up that includes a comparison of the outcome with surgery alone and chemotherapy alone are important. However, the fact that relapse can occur even after the treatment of metastases as a whole suggests that the disease must be treated with more than one modality.

Unverified Answer

What is ovary cancer?

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Ovary cancer is a rare tumour that affects older women. A woman's chances of developing an adnexal tumour increase significantly if she has had a hysterectomy. Ovary cancer typically occurs in the right ovary at the end of a chain of ovaries. The tumour can usually be recognised only when it causes abnormal bleeding or pain. Typically, symptoms have a very gradual onset. Ovary cancer can take on many different forms and may not be easily recognised under the microscope. It is classified as a malignant tumour and is treated surgically.

Unverified Answer

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

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Approximately 12.6 million women will be diagnosed with [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer) in the United States in 2019. Ovary cancer is the fourth leading cause of cancer death in women in the United States, and is expected to be the leading cause of cancer death within 20 years. The high burden and risk of incidence of ovarian cancer in the United States make prevention and early detection critical for improving survivorship.

Unverified Answer

What causes ovary cancer?

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Ovary cancer occurs mainly following the onset of menopause. Most ovary cancers develop from either pre-existing ovarian germ cell cancer or ovarian germ-cell carcinoma cells. The vast majority of ovary cancers carry mutations in either the BRCA1 or BRCA2 genes, suggesting that both women with BRCA1/BRCA2 mutations have a substantial risk of developing ovarian cancer, or both have autosomal recessive mutations. Genetic testing is recommended in all women who have had a first-degree relative with BRCA1/BRCA2-associated (especially ovarian) cancer. Screening should begin at the age of 55. The U.S.

Unverified Answer

Have there been any new discoveries for treating ovary cancer?

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In the last 10 years, there have been many breakthroughs for treating ovarian cancer. One example is bevacizumab (Avastin). Bevacizumab has been shown to be useful for improving survival and halting the spread of ovarian cancer. The mechanism of how the drug works is unclear.\n

Unverified Answer

How does bevacizumab work?

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In a recent study, findings suggest that bevacizumab does not enhance chemosensitivity to standard chemotherapeutic regimens in ovarian cancer. The rationale for this finding is a failure of bevacizumab to target the vasculature of ovarian tumours.

Unverified Answer

Who should consider clinical trials for ovary cancer?

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Findings from a recent study has found that trial eligibility and patient satisfaction are high, even when trial eligibility is very narrow. We believe this low level of exclusion supports patients' involvement in trial decision-making. Trials of novel anti-cancer therapies that target estrogen or anti-estrogen receptors should be offered to a large number of patients. Trials of other novel therapies that target the IGF signaling pathway should also be offered, specifically targeting HER2. Clinical trials can provide valuable information for patients in the form of trial results and treatment toxicity profiles. Furthermore, as with any drug or treatment, there is a subset of patients who may benefit from clinical trials and might not be eligible for enrollment. Clinicians must take this into account when evaluating patients for clinical trial enrollment.

Unverified Answer

Have there been other clinical trials involving bevacizumab?

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As with bevacizumab studies in patients with advanced breast cancer in combination with taxane, there would not be a single, specific indication for which bevacizumab would have been effective other than breast cancer with bevacizumab in combination with taxane. Data from a recent study suggest that studies in which bevacizumab was added to other anti-cancer regimens will likely have been insufficient.

Unverified Answer

What is the primary cause of ovary cancer?

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For most women with [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer), this disease results from the growth and spread (metastasis) of the cancer into the ovaries. In rare instances, ovarian cancer occurs as a result of the cancer growth in the ovaries. Some ovarian cancer cases are associated with genetic changes in specific genes and can occur in families; however, most cases occur sporadically. Cancer develops because the ovaries produce hormones that control most aspects of female physiology, including menstrual cycles, estrus cycles, pregnancy, and childbirth. These important hormonal functions help to keep the body from becoming too warm (heat stroke) or too cold (hypothermia). The development and progression of ovarian cancer occur because the ovaries produce hormones for these functions.

Unverified Answer
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