Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01837251




Registration number
NCT01837251
Ethics application status
Date submitted
16/04/2013
Date registered
23/04/2013
Date last updated
13/07/2021

Titles & IDs
Public title
Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer
Scientific title
A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer
Secondary ID [1] 0 0
AGO-OVAR 2.21 / ENGOT ov-18
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Platinum-sensitive Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Inflammatory and Immune System 0 0 0 0
Allergies
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
No intervention: Control Arm - Patients receive bevacizumab 15 mg/kg iv on day 1 followed by gemcitabine 1000mg/m² iv on day 1 \& 8 and carboplatin AUC4 iv on day 1 every 3 weeks for up to 6 cycles in the absence of progression disease or unacceptable toxicities. Patients then continue to receive bevacizumab 15 mg/kg iv every 3 weeks until progression disease or unacceptable toxicities.

Experimental: Research Arm - Patients receive bevacizumab 10 mg/kg iv on day 1 \& 15 followed by PLD 30mg/m² iv on day 1 carboplatin AUC4 iv on day 1 every 4 weeks for up to 6 cycles in the absence of progression disease or unacceptable toxicities. Patients then continue to receive bevacizumab 15 mg/kg iv every 3 weeks until progression disease or unacceptable toxicities.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
investigator-determined progression-free survival
Timepoint [1] 0 0
every 12 weeks until progression or up to 30 months (whichever occurs first)
Secondary outcome [1] 0 0
biological progression-free survival by serum CA 125
Timepoint [1] 0 0
every 3 weeks until progression or up to 30 months (whichever occurs first)
Secondary outcome [2] 0 0
Health related Quality of Life (QoL)
Timepoint [2] 0 0
Baseline and then every 12 weeks until investigator-determined progresssion-free survival and thereafter at every visit for th 5-years follow-up or death (whichever occurs first)
Secondary outcome [3] 0 0
Safety and Tolerability, i.e. type, frequency, severity and duration o adverse reactions
Timepoint [3] 0 0
every 3 weeks, 30 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
every 3 weeks during treatment with bevacizumab, thereafter every 6 months; for up 30 months

Eligibility
Key inclusion criteria
1. Histologically confirmed diagnosis of epithelial ovarian carcinoma or fallopian tube carcinoma or primary peritoneal carcinoma
2. First disease recurrence >6 months after first-line platinum-based chemotherapy
3. Patients with measurable or non-measurable disease (RECIST v1.1) or CA 125 assessable disease (GCIG criteria) or histological proven diagnosis of relapse
4. In case of cytoreductive surgery for recurrence, patients must be able to commence cytotoxic chemo-therapy within 8 weeks after cytoreductive surgery
5. ECOG PS 0-2
6. Absolute Neutrophil Count >= 1.5 x 10^9/L; Platelets >= 100 x 10^9/L; Hemoglobin >= 9.5 g/dL
7. Patients not receiving anticoagulant medication who have an International Normalized Ratio <= 1.5 and an Activated ProThrombin Time <= 1.5 x ULN
8. Serum bilirubin <= 2 x ULN; Serum transaminases <= 2.5 x ULN (<= 5 x ULN in the presence of liver metastasis)
9. Serum creatinine < 1.6 mg/dL or creatinine clearance >= 40 mL/min; Glomerular filtration rate > 40 ml/min (estimates based on the Cockroft-Gault or Jelliffe formula); Urine dipstick for proteinuria < 2+. If urine dipstick is >= 2+, 24 hour urine collection must demonstrate <= 1 g of protein in 24 hours
10. Normal blood pressure or adequately treated and controlled hypertension (either systolic BP = 140 mmHg and/or diastolic BP = 90 mmHg)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ovarian tumors of low malignant potential
2. Malignancies other than ovarian cancer within 5 years prior to randomization
3. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period
4. Any previous radiotherapy to the abdomen or pelvis
5. Known hypersensitivity to used chemotherapeutic agents in this trial and bevacizumab and its excipients, chinese hamster ovary cell products or other recombinant human or humanised antibodies
6. Current or recent chronic use of aspirin > 325 mg/day
7. Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of Bevacizumab
8. History of VEGF therapy related abdominal fistula or gastrointestinal perforation
9. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease
10. Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
11. Previous Cerebro-Vascular Accident , Transient Ischaemic Attack or Sub-Arachnoid Haemorrhage
12. Prior history of hypertensive crisis or hypertensive encephalopathy
13. Clinically significant disease, including: myocardial infarction or unstable angina within = 6 months of randomization; New York Heart Association (NYHA) >= grade 2 Congestive Heart Failure; poorly controlled cardiac arrhythmia despite medication; peripheral vascular disease grade >= 3
14. LVEF defined by ECHO/MUGA below the institutional lower limit of normal
15. Significant traumatic injury during 4 weeks prior to randomization
16. Current brain metastases or spinal cord compression
17. History or evidence upon neurological examination of central nervous system disease
18. Non-healing wound, active ulcer or bone fracture
19. History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to randomization
20. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic coagulation)
21. 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 duration of the trial and at least 6 months afterwards
22. Pregnant or lactating women
23. Requirement of therapeutic anticoagulation using marcumar, warfarin or PTT-prolonging heparin

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2021
Sample size
Target
Accrual to date
Final
682
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
NCCI - Coffs Harbour Hospital - Coffs Harbour
Recruitment hospital [4] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [5] 0 0
Peninsula Health - Frankston Hospital - Frankston
Recruitment hospital [6] 0 0
Andrew Love Cancer Centre Geelong - Geelong
Recruitment hospital [7] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [8] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [9] 0 0
St. George Hospital - Kogarah
Recruitment hospital [10] 0 0
ICON Cancer Care Centre - Milton
Recruitment hospital [11] 0 0
Nambour General Hospital - Nambour
Recruitment hospital [12] 0 0
Sir Charles Gairdner - Nedlands
Recruitment hospital [13] 0 0
North Coast Cancer Institute - Port Macquarie
Recruitment hospital [14] 0 0
Royal Hospital for Women - Randwick
Recruitment hospital [15] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [16] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [17] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [18] 0 0
St. John of God Hospital - Subiaco
Recruitment hospital [19] 0 0
Border Medical Oncology - Wodonga
Recruitment postcode(s) [1] 0 0
- Bankstown
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Coffs Harbour
Recruitment postcode(s) [4] 0 0
- Douglas
Recruitment postcode(s) [5] 0 0
- Frankston
Recruitment postcode(s) [6] 0 0
- Geelong
Recruitment postcode(s) [7] 0 0
- Herston
Recruitment postcode(s) [8] 0 0
- Hobart
Recruitment postcode(s) [9] 0 0
- Kogarah
Recruitment postcode(s) [10] 0 0
- Milton
Recruitment postcode(s) [11] 0 0
- Nambour
Recruitment postcode(s) [12] 0 0
- Nedlands
Recruitment postcode(s) [13] 0 0
- Port Macquarie
Recruitment postcode(s) [14] 0 0
- Randwick
Recruitment postcode(s) [15] 0 0
- South Brisbane
Recruitment postcode(s) [16] 0 0
- Southport
Recruitment postcode(s) [17] 0 0
- St. Leonards
Recruitment postcode(s) [18] 0 0
- Subiaco
Recruitment postcode(s) [19] 0 0
- Wodonga
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
Austria
State/province [4] 0 0
Salzburg
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
France
State/province [7] 0 0
Angers
Country [8] 0 0
France
State/province [8] 0 0
Avignon
Country [9] 0 0
France
State/province [9] 0 0
Blois
Country [10] 0 0
France
State/province [10] 0 0
Bordeaux
Country [11] 0 0
France
State/province [11] 0 0
Caen
Country [12] 0 0
France
State/province [12] 0 0
Chalon-Sur-Saone
Country [13] 0 0
France
State/province [13] 0 0
Cholet
Country [14] 0 0
France
State/province [14] 0 0
Clamart
Country [15] 0 0
France
State/province [15] 0 0
Clermont-Ferrand
Country [16] 0 0
France
State/province [16] 0 0
Draguignan
Country [17] 0 0
France
State/province [17] 0 0
Gap
Country [18] 0 0
France
State/province [18] 0 0
Grenoble
Country [19] 0 0
France
State/province [19] 0 0
La Roche sur Yon
Country [20] 0 0
France
State/province [20] 0 0
Levallois-Perret
Country [21] 0 0
France
State/province [21] 0 0
Lille
Country [22] 0 0
France
State/province [22] 0 0
Marseille
Country [23] 0 0
France
State/province [23] 0 0
Metz
Country [24] 0 0
France
State/province [24] 0 0
Mont de Marsan
Country [25] 0 0
France
State/province [25] 0 0
Montpellier
Country [26] 0 0
France
State/province [26] 0 0
Mulhouse
Country [27] 0 0
France
State/province [27] 0 0
Nancy
Country [28] 0 0
France
State/province [28] 0 0
Nantes
Country [29] 0 0
France
State/province [29] 0 0
Orleans
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
France
State/province [31] 0 0
Perpignan
Country [32] 0 0
France
State/province [32] 0 0
Périgueux
Country [33] 0 0
France
State/province [33] 0 0
Rennes
Country [34] 0 0
France
State/province [34] 0 0
Romans-sur-Isère
Country [35] 0 0
France
State/province [35] 0 0
Rouen
Country [36] 0 0
France
State/province [36] 0 0
Saint Brieuc
Country [37] 0 0
France
State/province [37] 0 0
Saint Herblain
Country [38] 0 0
France
State/province [38] 0 0
Saint Nazaire
Country [39] 0 0
France
State/province [39] 0 0
Strasbourg
Country [40] 0 0
France
State/province [40] 0 0
Thonon-les-Bains
Country [41] 0 0
France
State/province [41] 0 0
Toulouse
Country [42] 0 0
France
State/province [42] 0 0
Vannes
Country [43] 0 0
France
State/province [43] 0 0
Villeneuve d'Ascq
Country [44] 0 0
Germany
State/province [44] 0 0
Altötting
Country [45] 0 0
Germany
State/province [45] 0 0
Amberg
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Germany
State/province [46] 0 0
Aschaffenburg
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Germany
State/province [47] 0 0
Augsburg
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Germany
State/province [48] 0 0
Bad Homburg
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Germany
State/province [49] 0 0
Berlin
Country [50] 0 0
Germany
State/province [50] 0 0
Bochum
Country [51] 0 0
Germany
State/province [51] 0 0
Bonn
Country [52] 0 0
Germany
State/province [52] 0 0
Bottrop
Country [53] 0 0
Germany
State/province [53] 0 0
Brandenburg
Country [54] 0 0
Germany
State/province [54] 0 0
Braunschweig
Country [55] 0 0
Germany
State/province [55] 0 0
Bremen
Country [56] 0 0
Germany
State/province [56] 0 0
Chemnitz
Country [57] 0 0
Germany
State/province [57] 0 0
Darmstadt
Country [58] 0 0
Germany
State/province [58] 0 0
Deggendorf
Country [59] 0 0
Germany
State/province [59] 0 0
Dessau
Country [60] 0 0
Germany
State/province [60] 0 0
Dortmund
Country [61] 0 0
Germany
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Dresden
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Germany
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Düsseldorf
Country [63] 0 0
Germany
State/province [63] 0 0
Eggenfelden
Country [64] 0 0
Germany
State/province [64] 0 0
Erlangen
Country [65] 0 0
Germany
State/province [65] 0 0
Essen
Country [66] 0 0
Germany
State/province [66] 0 0
Esslingen
Country [67] 0 0
Germany
State/province [67] 0 0
Flensburg
Country [68] 0 0
Germany
State/province [68] 0 0
Frankfurt
Country [69] 0 0
Germany
State/province [69] 0 0
Freiburg
Country [70] 0 0
Germany
State/province [70] 0 0
Freudenstadt
Country [71] 0 0
Germany
State/province [71] 0 0
Fürth
Country [72] 0 0
Germany
State/province [72] 0 0
Georgsmarienhütte
Country [73] 0 0
Germany
State/province [73] 0 0
Gifhorn
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Germany
State/province [74] 0 0
Goslar
Country [75] 0 0
Germany
State/province [75] 0 0
Grafing
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Germany
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Greifswald
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Germany
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Halle
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Germany
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Hamburg
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Germany
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Hameln
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Germany
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Hanau
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Germany
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Hannover
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Germany
State/province [82] 0 0
Heidelberg
Country [83] 0 0
Germany
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Henstedt-Ulzburg
Country [84] 0 0
Germany
State/province [84] 0 0
Hildesheim
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Germany
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Itzehoe
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Germany
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Jena
Country [87] 0 0
Germany
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Karlsruhe
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Germany
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Kassel
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Germany
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Kempten
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Germany
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Kiel
Country [91] 0 0
Germany
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Konstanz
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Germany
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Kulmbach
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Germany
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Köln
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Germany
State/province [94] 0 0
Lich
Country [95] 0 0
Germany
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Limburg
Country [96] 0 0
Germany
State/province [96] 0 0
Lübeck
Country [97] 0 0
Germany
State/province [97] 0 0
Lüneburg
Country [98] 0 0
Germany
State/province [98] 0 0
Magdeburg
Country [99] 0 0
Germany
State/province [99] 0 0
Mainz
Country [100] 0 0
Germany
State/province [100] 0 0
Mannheim
Country [101] 0 0
Germany
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Marburg
Country [102] 0 0
Germany
State/province [102] 0 0
Minden
Country [103] 0 0
Germany
State/province [103] 0 0
München
Country [104] 0 0
Germany
State/province [104] 0 0
Münster
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Germany
State/province [105] 0 0
Neumarkt
Country [106] 0 0
Germany
State/province [106] 0 0
Neuss
Country [107] 0 0
Germany
State/province [107] 0 0
Nordhausen
Country [108] 0 0
Germany
State/province [108] 0 0
Nürnberg
Country [109] 0 0
Germany
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Offenbach
Country [110] 0 0
Germany
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Offenburg
Country [111] 0 0
Germany
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Osnabrück
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Germany
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Paderborn
Country [113] 0 0
Germany
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Pinneberg
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Germany
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Quedlinburg
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Germany
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Ravensburg
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Germany
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Rendsburg
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Germany
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Reutlingen
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Germany
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Rostock
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Germany
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Saalfeld
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Germany
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Saarbrücken
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Germany
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Salzgitter
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Germany
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Schweinfurt
Country [123] 0 0
Germany
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Schwerin
Country [124] 0 0
Germany
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Schwäbisch Hall
Country [125] 0 0
Germany
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Siegen
Country [126] 0 0
Germany
State/province [126] 0 0
Stadthagen
Country [127] 0 0
Germany
State/province [127] 0 0
Starnberg
Country [128] 0 0
Germany
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Stralsund
Country [129] 0 0
Germany
State/province [129] 0 0
Stuttgart
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Germany
State/province [130] 0 0
Suhl
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Germany
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Torgau
Country [132] 0 0
Germany
State/province [132] 0 0
Traunstein
Country [133] 0 0
Germany
State/province [133] 0 0
Trier
Country [134] 0 0
Germany
State/province [134] 0 0
Tübingen
Country [135] 0 0
Germany
State/province [135] 0 0
Ulm
Country [136] 0 0
Germany
State/province [136] 0 0
Viersen
Country [137] 0 0
Germany
State/province [137] 0 0
Villingen-Schwenningen
Country [138] 0 0
Germany
State/province [138] 0 0
Wetzlar
Country [139] 0 0
Germany
State/province [139] 0 0
Wiesbaden
Country [140] 0 0
Germany
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Wolfsburg
Country [141] 0 0
Germany
State/province [141] 0 0
Worms
Country [142] 0 0
Germany
State/province [142] 0 0
Zwickau
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Bangor
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Cardiff
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Glasgow
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Rhyl

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AGO Research GmbH
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
ARCAGY/ GINECO GROUP
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australia New Zealand Gynaecological Oncology Group
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Scottish Gynaecological Cancer Study Group
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jacobus Pfisterer, PhD MD
Address 0 0
AGO Study Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Pfisterer J, Shannon CM, Baumann K, Rau J, Harter ... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01837251