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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01837251
Ethics application status
Date submitted
16/04/2013
Date registered
23/04/2013
Date last updated
19/12/2018

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Carboplatin
Treatment: Drugs - PLD
Other interventions - Bevacizumab

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.


Treatment: Drugs: Carboplatin


Treatment: Drugs: PLD


Other interventions: Bevacizumab


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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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
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France
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Blois
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France
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Bordeaux
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France
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Caen
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France
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Chalon-Sur-Saone
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France
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Cholet
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France
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Clamart
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Clermont-Ferrand
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Draguignan
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Gap
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Grenoble
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La Roche sur Yon
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Levallois-Perret
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Lille
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Marseille
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Metz
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France
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Mont de Marsan
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Montpellier
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Mulhouse
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Nancy
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Nantes
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Orleans
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Paris
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Perpignan
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Périgueux
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Rennes
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Romans-sur-Isère
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Rouen
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Saint Brieuc
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Saint Herblain
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Saint Nazaire
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Strasbourg
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Toulouse
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Vannes
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Villeneuve d'Ascq
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Altötting
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Amberg
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Aschaffenburg
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Erlangen
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Essen
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Esslingen
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Flensburg
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Frankfurt
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Freiburg
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Freudenstadt
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Fürth
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Heidelberg
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Henstedt-Ulzburg
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Hildesheim
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Itzehoe
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Jena
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Karlsruhe
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Kassel
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Kempten
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Kiel
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Konstanz
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Kulmbach
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Köln
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Lich
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Limburg
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Lübeck
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Magdeburg
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Mainz
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Mannheim
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Marburg
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Minden
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München
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Münster
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Neuss
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Offenburg
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Paderborn
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Pinneberg
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Saarbrücken
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Salzgitter
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Schweinfurt
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Schwerin
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Siegen
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Stadthagen
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Starnberg
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Stralsund
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Stuttgart
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Suhl
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Torgau
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Traunstein
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Trier
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Tübingen
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Ulm
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Viersen
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Villingen-Schwenningen
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Wetzlar
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Wiesbaden
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Worms
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Zwickau
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Bangor
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Cardiff
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Glasgow
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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
Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer
when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and
PLD/carboplatin.
Trial website
https://clinicaltrials.gov/show/NCT01837251
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

Summary results
Other publications