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Ovarian CancerPhase 2NCT04787289

A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer

A Phase 2 study testing Bevacizumab in people with Ovarian Cancer and Platinum-resistant Ovarian Cancer, run by British Columbia Cancer Agency at 2 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 . Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
2 sitesCanada
Study dates
10 Sep 2021to 31 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 which no curative therapy exists.
  • 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 criteria on CT or MR.
  • 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
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  • 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 immunotherapy, hormone therapy, or PARP inhibitors.
  • 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, non-myelosuppressive radiotherapy after consultation with sponsor.
  • 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 "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgical sterility defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner.
  • 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 their willingness to participate.
  • Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their Legally Acceptable Representative (LAR) or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.
  • 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. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, response assessment, adverse events, and follow-up.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Jenny Ko contact

604-870-7488

jenny.ko@bccancer.bc.ca

Wilfred Hui contact

604-877-6000 ext. 4421

wilfred.hui@bccancer.bc.ca

Canada2 sites, 2 recruiting

  • Abbotsford Centre, BC Cancer Agency

    Abbotsford British Columbia, British Columbia, V2S 0C2

    Jenny Ko, MD, 604-851-7488, jenny.ko@bccancer.bc.ca

    Jenny Ko, MD

    Recruiting

  • BC Cancer - Vancouver

    Vancouver, British Columbia, V5Z4E6

    Wilfred W Hui, BSc, 604-877-6000 ext. 4421, wilfred.hui@bccancer.bc.ca

    Anna Tinker, MD

    Recruiting

Other trials in Canada

About this study

Official title: A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer - a Pragmatic Trial

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 . Higher doses of anti-cancer based drugs are not always better than lower doses and can cause more side effects without improvement of cancer. These patients will be randomly assigned either 7.5 mg/kg or 15mg/kg of bevacizumab combined with chemotherapy . Comparing these two doses will determine if the lower dose-level is non-inferior, and could lead to practice changes.

Read the detailed description

Study team proposes to compare 2 standard doses of an anti-cancer drug called bevacizumab, 7.5mg/kg per dose vs. 15mg/kg per dose, given in combination with chemotherapy in patients with ovarian cancer that progressed on platinum chemotherapy. Higher doses in cases of antibody-based drugs like bevacizumab are not always better than lower doses, and in fact can cause more side effects without improving survival or shrinkage of cancer. Both 7.5 and 15mg/kg doses of bevacizumab every 3 weeks are used as standard protocol in BC Cancer for ovarian cancer patients, but only 15mg/kg doses are allowed for patients with ovarian cancer that progressed on platinum chemotherapy. This study is a pragmatic two-arm blinded study in which 70 patients with platinum-resistant ovarian cancer and eligible for bevacizumab + chemotherapy will be randomly assigned either to lower or higher standard dose of bevacizumab , combined with chemotherapy. Treating clinicians will decide how long the treatment will continue per standard of care. Duration of cancer control on CT scans, side effect profiles, and quality of life related to the two arms will be compared. If demonstrated, this finding will be practice-changing, with comparable efficacy and quality of life, potentially improved safety profile, as well as reduced provincial drug costs.

Being tested
Bevacizumab
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Low standard dose of bevacizumab, combined with single agent chemotherapy (7.5mg/kg IV Q3w or 5mg/kg IV Q2w)

Study groups in NCT04787289
Study groupRoleWhat they receive
Higher Standard dosing as per standard regimenActive comparatorbevacizumab 15mg/kg + chemotherapy
Receives: Drug: Bevacizumab
Lower standard dosing bevacizumab plus chemotherapyExperimentalbevacizumab 7.5mg/kg + chemotherapy
Receives: Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival

    duration of time from registration to time progression

    Measured: 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

Secondary outcomes (5)

  1. Overall survival

    duration of time from registration to time of death from any cause.

    Measured: 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

  2. Duration of response

    Duration of response

    Measured: 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

  3. Compare treatment-emergent grade 3-5 AEs

    Compare treatment-emergent grade 3-5 AEs

    Measured: 4 months after last dose

  4. Quality of Life changes

    Quality of Life changes

    Measured: during treatment and 4 weeks after coming off treatment

  5. Estimate drug cost savings

    Estimate drug cost savings

    Measured: through study completion, up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2021
  2. Study start10 Sep 2021
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
244 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04787289
Sponsor's protocol ID
BEV-DOSE
Status last verified
Aug 2024
First submitted
1 Mar 2021
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab in people with Ovarian Cancer and Platinum-resistant Ovarian Cancer, run by British Columbia Cancer Agency at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jenny Ko (604-870-7488, jenny.ko@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04787289.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.

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