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

NCT04787289 | Recruiting Phase 2 DMC

• 1 other identifier: BEV-DOSE
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 2

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.

Conditions

Ovarian Cancer; Platinum-resistant Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  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

Secondary Outcomes (5)

• 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 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

• 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

• Estimate drug cost savings

  through study completion, up to 4 years

Study Arms (2)

Higher Standard dosing as per standard regimen

ACTIVE COMPARATOR

bevacizumab 15mg/kg + chemotherapy

Drug: Bevacizumab

Lower standard dosing bevacizumab plus chemotherapy

EXPERIMENTAL

bevacizumab 7.5mg/kg + chemotherapy

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

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

Higher Standard dosing as per standard regimen; Lower standard dosing bevacizumab plus chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (2)

Abbotsford Centre, BC Cancer Agency

Abbotsford, British Columbia, V2S 0C2, Canada

RECRUITING

BC Cancer - Vancouver

Vancouver, British Columbia, V5Z4E6, Canada

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jenny Ko

  BC Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Ko

CONTACT

604-870-7488; jenny.ko@bccancer.bc.ca

Wilfred Hui

CONTACT

604-877-6000; wilfred.hui@bccancer.bc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 8, 2021
• Study Start: September 10, 2021
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)