A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBritish Columbia Cancer Agency
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Chest x-ray > 20 mm
Disqualifiers
Patients with a history of other active or current malignancies that require active treatment.
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)
Trial design
Design model
Single group
Treatments tested in this trial
Bevacizumab
DrugLow standard dose of bevacizumab, combined with single agent chemotherapy (7.5mg/kg IV Q3w or 5mg/kg IV Q2w)
Treatment groups
244 Participants
are divided into 2 treatment groupsGroup A: Higher Standard dosing as per standard regimenActive comparator 1 intervention
Group B: Lower standard dosing bevacizumab plus chemotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
progression-free survival
duration of time from registration to time progression
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 monthsSecondary outcomes
1
Overall survival
duration of time from registration to time of death from any cause.
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 months2
Duration of response
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 months3
Compare treatment-emergent grade 3-5 AEs
Compare treatment-emergent grade 3-5 AEs
Time frame
4 months after last dose4
Quality of Life changes
Quality of Life changes
Time frame
during treatment and 4 weeks after coming off treatmentSponsors and contacts
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Source ClinicalTrials.gov