Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04787289
Other study ID # BEV-DOSE
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 10, 2021
Est. completion date January 31, 2025

Study information

Verified date July 2023
Source British Columbia Cancer Agency
Contact Jenny Ko
Phone 604-870-7488
Email jenny.ko@bccancer.bc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 . 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 244
Est. completion date January 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Abbotsford Centre, BC Cancer Agency Abbotsford British Columbia
Canada BC Cancer - Vancouver Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall survival duration of time from registration to time of death from any cause. 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 Duration of response 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
Secondary Compare treatment-emergent grade 3-5 AEs Compare treatment-emergent grade 3-5 AEs 4 months after last dose
Secondary Quality of Life changes Quality of Life changes during treatment and 4 weeks after coming off treatment
Secondary Estimate drug cost savings Estimate drug cost savings through study completion, up to 4 years
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2