- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01462890
Evaluation of Optimal Treatment Duration of Bevacizumab Combination With Standard Chemotherapy in Patients With Ovarian Cancer (BOOST)
A Prospective Randomised Phase III Trial to Evaluate Optimal Treatment Duration of First-line Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Primary Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Aalborg, Denmark
-
Copenhagen, Denmark
-
Herlev, Denmark
-
-
-
-
-
Kuopio, Finland
-
Oulu, Finland
-
Tampere, Finland
-
Turku, Finland
-
-
-
-
-
Angers, France
-
Besancon, France
-
Blois, France
-
Bordeaux, France
-
Caen, France
-
Cahors, France
-
Clamart, France
-
Clermont-Ferrand, France
-
Creteil, France
-
Dax, France
-
Draguignan, France
-
Grenoble, France
-
Limoges, France
-
Lyon, France
-
Mougins, France
-
Nancy, France
-
Nantes, France
-
Nice, France
-
Nimes, France
-
Orleans, France
-
Paris, France
-
Pau, France
-
Plérin, France
-
Poitiers, France
-
Quimper, France
-
Reims, France
-
Rouen, France
-
Saint-Herblain, France
-
Strasbourg, France
-
Toulouse, France
-
Vandoeuvre-Les-Nancy, France
-
Vannes, France
-
Villejuif, France
-
-
-
-
-
Aachen, Germany
-
Arnsberg, Germany
-
Aschaffenburg, Germany
-
Augsburg, Germany
-
Bad Homburg vor der Höhe, Germany
-
Berlin, Germany
-
Bochum, Germany
-
Bonn, Germany
-
Bottrop, Germany
-
Brandenburg, Germany
-
Bremen, Germany
-
Chemnitz, Germany
-
Coburg, Germany
-
Deggendorf, Germany
-
Dessau, Germany
-
Dresden, Germany
-
Düsseldorf, Germany
-
Ebersberg, Germany
-
Eggenfelden, Germany
-
Erlangen, Germany
-
Essen, Germany
-
Esslingen, Germany
-
Flensburg, Germany
-
Frankfurt/M., Germany
-
Freiburg, Germany
-
Fürstenfeldbruck, Germany
-
Fürth, Germany
-
Georgsmarienhütte, Germany
-
Gera, Germany
-
Greifswald, Germany
-
Göttingen, Germany
-
Gütersloh, Germany
-
Halle (Saale), Germany
-
Hamburg, Germany
-
Hanau am Main, Germany
-
Hannover, Germany
-
Heidelberg, Germany
-
Henstedt-Ulzburg, Germany
-
Hildesheim, Germany
-
Jena, Germany
-
Kaiserslautern, Germany
-
Karlsruhe, Germany
-
Kassel, Germany
-
Kiel, Germany
-
Krefeld, Germany
-
Köln, Germany
-
Lich, Germany
-
Limburg, Germany
-
Lübeck, Germany
-
Lüneburg, Germany
-
Magdeburg, Germany
-
Mainz, Germany
-
Mannheim, Germany
-
Marburg, Germany
-
Minden, Germany
-
München, Germany
-
Neumarkt, Germany
-
Neuss, Germany
-
Nordhausen, Germany
-
Offenbach, Germany
-
Offenburg, Germany
-
Oldenburg, Germany
-
Osnabrück, Germany
-
Ravensburg, Germany
-
Regensburg, Germany
-
Reutlingen, Germany
-
Rosenheim, Germany
-
Rostock, Germany
-
Rottweil, Germany
-
Saalfeld, Germany
-
Salzgitter, Germany
-
Schweinfurt, Germany
-
Schwäbisch Hall, Germany
-
Sigmaringen, Germany
-
Solingen, Germany
-
Stralsund, Germany
-
Stuttgart, Germany
-
Torgau, Germany
-
Trier, Germany
-
Tübingen, Germany
-
Ulm, Germany
-
Viersen, Germany
-
Wiesbaden, Germany
-
Witten, Germany
-
Wolfsburg, Germany
-
Worms, Germany
-
-
-
-
-
Bergen, Norway
-
Oslo, Norway
-
Trondheim, Norway
-
-
-
-
-
Falun, Sweden
-
Uppsala, Sweden
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed written informed consent obtained prior to initiation of any study specific procedures and treatment as confirmation of the patients awareness and willingness to comply with the study requirements
- Primary diagnosis is confirmed by specialized pathology review (Germany only)
- Females aged ≥ 18 years
Histologically confirmed, newly diagnosed
- Epithelial ovarian carcinoma
- Fallopian tube carcinoma
- Primary peritoneal carcinoma AND FIGO stage IIb - IV (all grades and all histological types)
Patients should have already undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction according to the GCIG Conference Consensus Statement. There must be no planned surgical debulking prior to disease progression. Patients with stage III and IV disease in whom initial surgical debulking was not appropriate or possible will still be eligible providing
- the patient has a histological diagnosis and
- debulking surgery prior to disease progression is not foreseen
- Patients must be able to commence cytotoxic chemotherapy within 8 weeks of cytoreductive surgery. The first dose of bevacizumab can be omitted in both arms if the investigator decides to start chemotherapy within 4 weeks of surgery.
- ECOG 0-2
- Life expectancy > 3 months
Adequate bone marrow function (within 14 days prior to randomization)
- ANC ≥ 1.5 x 10^9/L
- PLT ≥ 100 x 10^9/L
- Hb ≥ 9 g/dL (can be post-transfusion)
Adequate coagulation parameters (within 14 days prior to randomization)
- Patients not receiving anticoagulant medication who have an INR ≤ 1.5 and an aPTT ≤ 1.5 x ULN
- The use of full-dose oral or par-enteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to institution medical standard) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of randomization.
Adequate liver function (within 14 days prior to randomization)
- Serum bilirubin ≤ 1.5 x ULN
- Serum transaminases ≤ 2.5 x ULN
- Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours
- Adequate postoperative GFR > 40 ml/min (estimates based on the Cockroft-Gault or Jelliffe formula are sufficient)
Exclusion Criteria:
- Non-epithelial origin of the ovary, the fallopian tube or the peritoneum
- Borderline tumours (tumours of low malignant potential) and FIGO stage Ia - IIa tumours
- Planned intraperitoneal cytotoxic chemotherapy
- Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)
- Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for the fact that bevacizumab can be omitted from the first cycle of chemotherapy). It is strongly recommended that an interval of 7 days is left between the insertion of any central venous access devices (CVADs) and the onset of bevacizumab treatment.
- Any planned surgery during the study treatment period plus 4 additional weeks to allow for bevacizumab clearance
- Uncontrolled hypertension (sustained elevation of BP systolic > 150mmHg and/or diastolic > 100mmHg despite antihypertensive therapy)
- Any previous radiotherapy to the abdomen or pelvis
- Significant traumatic injury during 4 weeks preceding the potential first dose of bevacizumab
- History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression.
- History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy e.g. uncontrolled seizures
- Previous Cerebro-Vascular Accident (CVA), Transient Ischaemic Attack (TIA) or Sub-Arachnoid Haemorrhage (SAH) within 6 months prior to randomization
- Fertile woman of childbearing potential not willing to use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least 6 months afterwards
- Pregnant or lactating women
- Treatment with other investigational agents, or participation in another clinical trial testing a drug within the past 4 weeks before start of therapy concomitantly with this trial
Malignancies other than ovarian cancer within 5 years prior to randomization, except for adequately treated
- carcinoma in situ of the cervix
- and/or basal cell skin cancer
- and/or non-melanomatous skin cancer
- carcinoma in situ of the breast
- and/or early endometrial carcinoma as specified below. Patients may have received previous adjuvant chemotherapy for other malignancies e.g. breast or colorectal carcinoma if diagnosed over 5 years ago with no evidence of subsequent recurrence.
Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met
- Disease stage FIGO stage ≤ IA (tumour invades less than one half of the myometrium)
- Known hypersensitivity to bevacizumab and its excipients, Chinese hamster ovary cell products or other recombinant human or humanised antibodies
- Non healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require 3 weekly wound examinations
- History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to randomization
Clinically significant cardiovascular disease, including
- Myocardial infarction or unstable angina within 6 months of randomization
- NYHA ≥ Grade 2 Congestive Heart Failure (CHF)
- Poorly controlled cardiac arrhythmia despite medication (patients with rate-controlled atrial fibrillation are eligible)
- Grade ≥ 3 peripheral vascular disease (i.e. symptomatic and interfering with activities of daily living requiring repair or revision)
- Current or recent (within 10 days prior to randomization) chronic use of aspirin > 325 mg/day
- Pre-existing sensory or motor neuropathy ≥ Grade 2
- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control Arm
Patients receive bevacizumab iv followed by paclitaxel iv and carboplatin iv on day 1.
Treatment repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Patients then continue to receive bevacizumab iv alone every 3 weeks for 16 cycles.
|
15 mg/kg, iv on day 1 every 3 weeks up to and including cycle 22 vs cycle 44
175 mg/m², iv on day 1 every 3 weeks for 6 cycles
AUC 5, iv on day 1 every 3 weeks for 6 cycles
before randomization
|
Experimental: Research Arm
Patients receive bevacizumab iv followed by paclitaxel iv and carboplatin iv on day 1.
Treatment repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Patients then continue to receive bevacizumab iv alone every 3 weeks for 38 cycles.
|
175 mg/m², iv on day 1 every 3 weeks for 6 cycles
AUC 5, iv on day 1 every 3 weeks for 6 cycles
before randomization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free Survival (PFS)
Time Frame: every 12 weeks until progression or up to 30 months, thereafter every 6 months
|
every 12 weeks until progression or up to 30 months, thereafter every 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: every 12 weeks until progression or up to 30 months, thereafter every 6 months
|
every 12 weeks until progression or up to 30 months, thereafter every 6 months
|
|
Overall survival (OS)
Time Frame: every 3 weeks, 31 months after start of treatment, thereafter every 6 months
|
every 3 weeks, 31 months after start of treatment, thereafter every 6 months
|
|
Health related Quality of life (QoL)
Time Frame: baseline, then every 12 weeks until progression, 31 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
|
baseline, then every 12 weeks until progression, 31 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
|
|
Safety and tolerability, i.e. type, frequency, severity and duration of adverse reactions
Time Frame: every 3 weeks, 31 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
|
every 3 weeks, 31 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
|
|
Translational Research - Tumor Tissue Block
Time Frame: Assessment at end of study planned
|
may be obtained at any time during therapy, preferably at cycle 1 or at a subsequent visit
|
Assessment at end of study planned
|
Translational Research - Complementary and Alternative Treatment Questionnaires
Time Frame: baseline, 6 months and 12 months after start of treatment, if required at timepoint of treatment termination
|
baseline, 6 months and 12 months after start of treatment, if required at timepoint of treatment termination
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jacobus Pfisterer, MD PhD, AGO Study Group
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Peritoneal Diseases
- Genital Neoplasms, Female
- Endocrine System Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Abdominal Neoplasms
- Neoplasms
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Ovarian Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Carboplatin
- Paclitaxel
- Bevacizumab
Other Study ID Numbers
- AGO-OVAR 17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Diseases
-
Forever Young d.o.o.Medigroup Health System, Jevremova hospital; Saint James Hospital Malta; Re-medika...UnknownMenopause | Menopause, Premature | Premature Ovarian Failure | Ovarian Failure, Premature | Ovarian Failure | Ovarian Insufficiency | Ovarian Insufficiency, Primary | Premature Ovarian Failure 2A | Premature Ovarian Failure 3 | Premature Ovarian Failure 4 | Premature Ovarian Failure 1 | Premature Ovarian Failure... and other conditionsMalta, North Macedonia, Serbia
-
Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
Ascendance BiomedicalCompletedInfertility | Menopause | Menopause, Premature | Infertility, Female | Premature Ovarian Failure | Menopause Related Conditions | Perimenopausal Disorder | Infertility Unexplained | Menopause Premature Symptomatic | Menopause Premature Asymptomatic | Premature Ovarian Failure, Familial | Premature Ovarian Failure... and other conditionsUnited States
-
Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedRecurrent Ovarian Carcinoma | Ovarian Neoplasm | Ovarian Clear Cell Tumor | Adnexal Mass | Ovarian Endometrioid Tumor | Ovarian Serous Tumor | Borderline Ovarian Epithelial TumorUnited States
-
Center for Human ReproductionRecruitingDiminished Ovarian Reserve | Ovarian FailureUnited States
-
Barzilai Medical CenterRecruitingPoor Ovarian Response | Ovarian InsufficiencyIsrael
-
Maastricht University Medical CenterVieCuri Medical Centre; Orbis Medical Centre; St.Jans Gasthuis Weert; Laurentius...TerminatedOvarian Cancer | Ovarian Carcinoma | Ovarian Cyst | Ovarian MassNetherlands
-
Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
Clinical Trials on Bevacizumab
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Serous Cystadenocarcinoma | Endometrial Clear Cell Adenocarcinoma | Endometrial Serous Adenocarcinoma | Recurrent... and other conditionsUnited States
-
National Cancer Institute (NCI)NRG OncologyCompletedGlioblastoma | Gliosarcoma | Recurrent Glioblastoma | Oligodendroglioma | Giant Cell Glioblastoma | Recurrent Brain NeoplasmUnited States, Canada
-
M.D. Anderson Cancer CenterRecruitingStage IB Hepatocellular Carcinoma AJCC v8 | Stage II Hepatocellular Carcinoma AJCC v8 | Resectable Hepatocellular Carcinoma | Stage I Hepatocellular Carcinoma AJCC v8 | Stage IA Hepatocellular Carcinoma AJCC v8United States
-
National Cancer Institute (NCI)Active, not recruitingOvarian Endometrioid Adenocarcinoma | Primary Peritoneal High Grade Serous Adenocarcinoma | Fallopian Tube Endometrioid Adenocarcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Ovarian High Grade Serous Adenocarcinoma | Platinum-Resistant... and other conditionsUnited States, Canada
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Fallopian Tube Adenocarcinoma | Fallopian Tube Serous Adenocarcinoma | Ovarian Serous Adenocarcinoma | Fallopian Tube... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Stage IVA Cervical Cancer AJCC v6 and v7 | Recurrent Cervical Carcinoma | Stage IV Cervical Cancer AJCC v6 and v7 | Stage IVB Cervical Cancer AJCC v6 and v7United States
-
Northwestern UniversityNational Cancer Institute (NCI); Ipsen BiopharmaceuticalsCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Refractory Ovarian Carcinoma | Refractory Fallopian Tube... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Merck Sharp & Dohme LLC; Celldex TherapeuticsRecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Recurrent Endometrial Serous Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma | Platinum-Sensitive Ovarian Carcinoma | Recurrent Fallopian... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingStage IV Cutaneous Melanoma AJCC v6 and v7 | Stage IIIC Cutaneous Melanoma AJCC v7 | Unresectable MelanomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Lung Non-Small Cell Carcinoma | Stage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage IIIC Lung Cancer AJCC v8 | Locally Advanced Lung Non-Small... and other conditionsUnited States