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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04787289
Recruitment Status : Not yet recruiting
First Posted : March 8, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Jenny Ko, British Columbia Cancer Agency

Brief 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 . 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Platinum-resistant Ovarian Cancer Drug: Bevacizumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer - a Pragmatic Trial
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Active Comparator: Higher Standard dosing as per standard regimen
bevacizumab 15mg/kg + chemotherapy
Drug: Bevacizumab
Low standard dose of bevacizumab, combined with single agent chemotherapy (7.5mg/kg IV Q3w or 5mg/kg IV Q2w)

Experimental: Lower standard dosing bevacizumab plus chemotherapy
bevacizumab 7.5mg/kg + chemotherapy
Drug: Bevacizumab
Low standard dose of bevacizumab, combined with single agent chemotherapy (7.5mg/kg IV Q3w or 5mg/kg IV Q2w)




Primary Outcome Measures :
  1. 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 ]
    duration of time from registration to time progression


Secondary Outcome Measures :
  1. Overall 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 ]
    duration of time from registration to time of death from any cause.

  2. Duration of response [ Time Frame: 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

  3. Compare treatment-emergent grade 3-5 AEs [ Time Frame: 4 months after last dose ]
    Compare treatment-emergent grade 3-5 AEs

  4. Quality of Life changes [ Time Frame: during treatment and 4 weeks after coming off treatment ]
    Quality of Life changes

  5. Estimate drug cost savings [ Time Frame: through study completion, up to 4 years ]
    Estimate drug cost savings



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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 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
    • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04787289


Contacts
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Contact: Jenny Ko 604-870-7488 jenny.ko@bccancer.bc.ca
Contact: Wilfred Hui 604-877-6000 ext 4421 wilfred.hui@bccancer.bc.ca

Locations
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Canada, British Columbia
Abbotsford Centre, BC Cancer Agency
Abbotsford, British Columbia, Canada, V2S 0C2
Contact: Jenny Ko, MD    604-851-7488    jenny.ko@bccancer.bc.ca   
Principal Investigator: Jenny Ko, MD         
Sponsors and Collaborators
British Columbia Cancer Agency
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Responsible Party: Jenny Ko, Medical Oncologist, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT04787289    
Other Study ID Numbers: BEV-DOSE
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors