BridgeMD
New treatment option for Ovarian Cancer
Official title A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer
ClinicalTrials.gov ID: NCT04787289
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A pragmatic, two armed, study comparing 2 standard doses of an anti-cancer drug called bevacizumab, given in combination with Chemotherapy. The study will be offered to ovarian cancer patients whose disease is platinum chemotherapy resistant .
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Histologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal, or fallopian tube carcinoma according to WHO Classification of...
- Platinum resistant disease (progression within six months of completing a platinum-containing protocol). In this case, progression from the last line...
- Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days of randomization.
- All patients must have measurable disease as defined by RECIST 1.1. The criteria for defining measurable disease are as follows:
- Chest x-ray \> 20 mm
You likely can't join if
- Patients with a history of other active or current malignancies that require active treatment.
- Patients with serious illness or medical conditions that might be aggravated by treatment or limit compliance including, but not limited to:
- History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study...
- Uncontrolled hypertension
- Active uncontrolled or serious infection (viral, bacterial or fungal)
- Other medical conditions that might be aggravated by study treatment
See the full eligibility criteria
- Histologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal, or fallopian tube carcinoma according to WHO Classification of tumours that is advanced/metastatic/recurrent or unresectable and for...
- Platinum resistant disease (progression within six months of completing a platinum-containing protocol). In this case, progression from the last line of therapy would be defined as radiologic progression by RECIST 1.1...
- Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days of randomization.
- All patients must have measurable disease as defined by RECIST 1.1. The criteria for defining measurable disease are as follows:
- Chest x-ray \> 20 mm
- CT scan (with slice thickness of 5 mm) \> 10 mm longest diameter
- Physical exam (using calipers) \> 10 mm Lymph nodes by CT scan \> 15 mm measured in short axis
- Patients must be \>= 18 years of age.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Any number of prior lines of treatment is permitted. However, all patients must have received at least one prior regimen of chemotherapy including platinum. All patients may have received other therapies including...
- Patients must have never received an anti-angiogenesis inhibitor including bevacizumab.
- A BC Cancer "Compassionate Access Program" (CAP) request must be approved prior to treatment
- Radiation: prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of treatment initiation. Exceptions may be made for low-dose...
- Surgery: Previous surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of randomization/registration, and that wound healing has occurred.
- Women of childbearing potential must have agreed to use a highly effective contraceptive method during the study and for up to 5 months after the last dose of chemotherapy/bevacizumab. A woman is considered to be of...
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to any study specific procedures (see Section 6.0) to document...
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits...
- Patients with a history of other active or current malignancies that require active treatment.
- Patients with serious illness or medical conditions that might be aggravated by treatment or limit compliance including, but not limited to:
- History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.
- Uncontrolled hypertension
- Active uncontrolled or serious infection (viral, bacterial or fungal)
- Other medical conditions that might be aggravated by study treatment
- Patients receiving concurrent treatment with other anti-cancer therapy or investigational agents.
- Neutrophils less than 1 x 10\^9 /L
- Pregnancy or breastfeeding
- Bleeding diathesis
- History of bowel obstruction or unresolved bowel obstruction (refer to the BC Cancer protocols above)
- Uncontrolled arterial or venous thromboembolism (note: once controlled, patient may still be eligible).
- Myocardial infarction (MI) or cerebrovascular accident (CVA) within 4 months.
- Untreated or uncontrolled central nervous system (CNS) metastatic disease.
- Open, non-healing wounds or known fistulas that have not healed.
The study team makes the final eligibility decision.
Where it's taking place
- Abbotsford British Columbia, British Columbia, Canada
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Abbotsford British Columbia, British Columbia, Canada; Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.