Phase
Condition
Malignant Ascites
Fallopian Tube Cancer
Digestive System Neoplasms
Treatment
N/AClinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
Newly diagnosed disease
Meets 1 of the following staging criteria:
High-risk stage I or IIA disease (grade 3 disease or clear cell carcinoma only)
Stage IIB-IV disease (all grades and all histological types)
Must have undergone initial surgery (e.g., debulking cytoreductive surgery or a biopsy if the patient has stage IV disease) within the past 6 weeks
Patients with stage IV disease for which initial surgical debulking was not appropriate are eligible provided the following criteria are met:
Stage IV disease diagnosed by histology
No planned surgery prior to disease progression, including interval debulking surgery
Patients with prior early-stage ovarian epithelial or fallopian tube carcinoma treated with surgery alone are eligible at the time of diagnosis of abdominopelvic recurrence provided no further interval cytoreductive therapy is planned prior to disease progression
Synchronous primary endometrial carcinoma or a past history of primary endometrial carcinoma allowed provided the following criteria are met:
Disease ≤ stage IB
No more than superficial myometrial invasion
No lymphovascular invasion
Not poorly differentiated (i.e., no grade 3, papillary serous, or clear cell disease)
Measurable or nonmeasurable disease
No ovarian nonepithelial cancer, including malignant mixed Müllerian tumors
No borderline tumors (e.g., tumors of low malignant potential)
No history or clinical suspicion of brain metastases or spinal cord compression
CT scan or 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
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Life expectancy > 12 weeks
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9 g/dL (can be post-transfusion)
INR ≤ 1.5
APTT ≤ 1.5 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 times ULN
ALT and AST ≤ 2.5 times ULN
Creatinine ≤ 2.0 mg/dL
Proteinuria ≤ 1+ by urine dipstick OR ≤ 1 g by 24-hour urine collection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 6 weeks after completion of study therapy
No significant traumatic injury within the past 4 weeks
No cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
No other malignancies within the past 5 years except for adequately treated carcinoma in situ of the cervix, and/or basal cell skin cancer, and/or early endometrial carcinoma
No pre-existing sensory or motor neuropathy ≥ grade 2
No history or evidence of CNS disease (e.g., uncontrolled seizures) by neurological examination unless adequately treated with standard medical therapy
No history or evidence of thrombotic or hemorrhagic disorders
No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg despite antihypertensive therapy)
No known hypersensitivity to bevacizumab and its excipients, chemotherapy, or Cremophor EL
No nonhealing wound, ulcer, or bone fracture
Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require three weekly wound examinations
No clinically significant cardiovascular disease, including any of the following:
Myocardial infarction or unstable angina within the past 6 months
New York Heart Association class II-IV congestive heart failure
Poorly controlled cardiac arrhythmia despite medication
Rate-controlled atrial fibrillation allowed
Peripheral vascular disease ≥ grade 3 (i.e., symptomatic and interfering with activities of daily living requiring repair or revision)
No evidence of other disease or condition, metabolic dysfunction, physical examination findings, or laboratory findings that would contraindicate the use of an investigational drug or put the patient at high-risk for treatment-related complications
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
More than 4 weeks since other prior surgery or open biopsy
No prior systemic therapy for ovarian cancer (e.g., chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy, or hormonal therapy)
Prior adjuvant chemotherapy allowed for other malignancies (e.g., breast or colorectal carcinoma) if malignancy was diagnosed over 5 years ago with no evidence of subsequent recurrence
No prior mouse CA 125 antibody
No prior radiotherapy to the abdomen or pelvis
More than 10 days since prior and no concurrent chronic use of acetylsalicylic acid (> 325 mg/day)
Low-dose (< 325 mg/day) acetylsalicylic acid allowed
More than 10 days since prior and no concurrent full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes
Use of therapy for line patency allowed provided INR < 1.5
More than 30 days since prior and no other concurrent investigational agent or participation in another clinical trial
No other concurrent systemic antitumor agents
No concurrent surgery
No concurrent maintenance chemotherapy or intraperitoneal chemotherapy (including cytotoxic chemotherapy)
Study Design
Study Description
Connect with a study center
Cancer Therapy Centre at Liverpool Hospital
Liverpool, New South Wales 2170
AustraliaSite Not Available
Prince of Wales Private Hospital
Randwick, New South Wales 2031
AustraliaSite Not Available
Royal North Shore Hospital
St. Leonards, New South Wales 2065
AustraliaSite Not Available
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales 2050
AustraliaSite Not Available
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales 2298
AustraliaSite Not Available
Westmead Institute for Cancer Research at Westmead Hospital
Wentworthville, New South Wales 2145
AustraliaSite Not Available
Royal Brisbane and Women's Hospital
Brisbane, Queensland 4029
AustraliaSite Not Available
Mater Adult Hospital
South Brisbane, Queensland 4101
AustraliaSite Not Available
Royal Adelaide Hospital Cancer Centre
Adelaide, South Australia 5000
AustraliaSite Not Available
Royal Hobart Hospital
Hobart, Tasmania 7000
AustraliaSite Not Available
Box Hill Hospital
Box Hill, Victoria 3128
AustraliaSite Not Available
Royal Women's Hospital
Carlton, Victoria 3053
AustraliaSite Not Available
Mercy Hospital for Women
East Melbourne, Victoria 3002
AustraliaSite Not Available
Frankston Hospital
Frankston, Victoria 3199
AustraliaSite Not Available
Murray Valley Private Hospital and Cancer Treatment Centre
Wodonga, Victoria 3690
AustraliaSite Not Available
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia 6009
AustraliaSite Not Available
Centre Paul Papin
Angers, 49100
FranceSite Not Available
Institut Sainte Catherine
Avignon, 84082
FranceSite Not Available
Clinique Tivoli
Bordeaux, F-33000
FranceSite Not Available
Institut Bergonie
Bordeaux, 33076
FranceSite Not Available
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
FranceSite Not Available
Centre Regional Francois Baclesse
Caen, 14076
FranceSite Not Available
Centre Jean Perrin
Clermont-Ferrand, 63011
FranceSite Not Available
Hopital Louis Pasteur
Colmar, 68024
FranceSite Not Available
CHU de Grenoble - Hopital de la Tronche
Grenoble, 38043
FranceSite Not Available
Institut Prive de Cancerologie
Grenoble, 38100
FranceSite Not Available
Hopital Andre Mignot
Le Chesnay, 78157
FranceSite Not Available
Centre Jean Bernard
Le Mans, 72000
FranceSite Not Available
Centre Leon Berard
Lyon, 69373
FranceSite Not Available
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
FranceSite Not Available
Centre D'Oncologie De Gentilly
Nancy, 54100
FranceSite Not Available
Centre Catherine de Sienne
Nantes, 02
FranceSite Not Available
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, 44805
FranceSite Not Available
Hopital Cochin
Paris, 75674
FranceSite Not Available
Hopital Europeen Georges Pompidou
Paris, 75015
FranceSite Not Available
Hopital Tenon
Paris, 75970
FranceSite Not Available
Hotel Dieu de Paris
Paris, 75181
FranceSite Not Available
Institut Curie Hopital
Paris, 75020
FranceSite Not Available
Centre Hospitalier Lyon Sud
Pierre Benite, 69495
FranceSite Not Available
Centre Henri Becquerel
Rouen, 76038
FranceSite Not Available
Clinique Armoricaine De Radiologie
Saint Brieuc, F-22015
FranceSite Not Available
Centre Rene Huguenin
Saint Cloud, 92211
FranceSite Not Available
Hopital Universitaire Hautepierre
Strasbourg, 67098
FranceSite Not Available
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, 37044
FranceSite Not Available
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, 54511
FranceSite Not Available
Charite University Hospital - Campus Virchow Klinikum
Berlin, D-13353
GermanySite Not Available
Evang. Waldkrankenhaus Spandau
Berlin, 13589
GermanySite Not Available
Klinikum Bremen-Mitte
Bremen, D-28205
GermanySite Not Available
Praxis Dres. F.& G. Doering
Bremen, D-28205
GermanySite Not Available
Klinikum Chemnitz gGmbH
Chemnitz, D-09116
GermanySite Not Available
Universitatsklinikum Carl Gustav Carus
Dresden, D-01307
GermanySite Not Available
Kreiskrankenhaus
Ebersberg, D-85560
GermanySite Not Available
Elisabeth-Krankenhaus
Essen, D-45138
GermanySite Not Available
Universitaetsklinikum Essen
Essen, D-45122
GermanySite Not Available
Staedtische Kliniken Esslingen
Esslingen, D-73730
GermanySite Not Available
Klinikum der J.W. Goethe Universitaet
Frankfurt, D-60590
GermanySite Not Available
Onkologie Bethanien
Frankfurt, D-60389
GermanySite Not Available
Staedtische Kliniken Frankfurt am Main - Hoechst
Frankfurt, D-65929
GermanySite Not Available
Universitaetsfrauenklinik Freiburg
Freiburg, D-79106
GermanySite Not Available
Franziskus Hospital Hardenberg
Georgsmarienhuette, D-49124
GermanySite Not Available
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, D-17487
GermanySite Not Available
Universitaetsklinikum Halle
Halle, D-06097
GermanySite Not Available
Henriettenstiftung Frauenklinik
Hannover, D-30559
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover, D-30625
GermanySite Not Available
St. Vincentius - Kliniken
Karlsruhe, D-76137
GermanySite Not Available
Klinikum Kassel
Kassel, D-34125
GermanySite Not Available
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, D-24105
GermanySite Not Available
Kreiskrankenhaus Lahr
Lahr, D-77993
GermanySite Not Available
Kreiskrankenhaus Leonberg - Frauenklinik
Leonberg, D-71229
GermanySite Not Available
Asklepios Klinik Lich
Lich, D-35423
GermanySite Not Available
St. Vincenz Hospital Limburg
Limburg, D-65549
GermanySite Not Available
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Luebeck, D-23538
GermanySite Not Available
Staedtisches Klinikum Lueneburg
Lueneburg, D-21339
GermanySite Not Available
Klinik St. Marienstift Magdeburg
Magdeburg, D-39110
GermanySite Not Available
St. Vincenz und Elisabeth Hospital
Mainz, 55131
GermanySite Not Available
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
Marburg, D-35043
GermanySite Not Available
Klinikum Minden
Minden, D-32423
GermanySite Not Available
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
Munich, D-80337
GermanySite Not Available
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, D-81675
GermanySite Not Available
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, D-81377
GermanySite Not Available
Staedtisches Klinikum Neunkirchen gGmbH
Neunkirchen, D-66538
GermanySite Not Available
Lukaskrankenhaus Neuss
Neuss, D-41464
GermanySite Not Available
Klinikum Offenback GmbH
Offenbach, D-63069
GermanySite Not Available
Saint Vincenz-Krankenhaus Paderborn
Paderborn, 33098
GermanySite Not Available
Klinikum Dorothea Christiane Erxleben - Quedlingburg
Quedlinburg, D-06484
GermanySite Not Available
Krankenhaus St. Elisabeth - Ravensburg
Ravensburg, D-88212
GermanySite Not Available
St. Marien - Krankenhaus Siegen GMBH
Siegen, D-57072
GermanySite Not Available
Kliniken Landkreis Sigmaringen GMBH
Sigmaringen, D-72488
GermanySite Not Available
Marienhospital Stuttgart
Stuttgart, D-70199
GermanySite Not Available
Robert-Bosch-Krankenhaus
Stuttgart, 70376
GermanySite Not Available
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, D-89081
GermanySite Not Available
Dr. Horst-Schmidt-Kliniken
Wiesbaden, D-65199
GermanySite Not Available
Marien-Hospital Witten
Witten, 58452
GermanySite Not Available
Klinikum der Stadt Wolfsburg
Wolfsburg, D-38440
GermanySite Not Available
Praxis Fuer Haemotologie Und Internistischer Onkologie
Wuppertal, 42105
GermanySite Not Available
Norwegian Radium Hospital
Oslo, N-0310
NorwaySite Not Available
North Devon District Hospital
Barnstaple, England EX31 4JB
United KingdomSite Not Available
Broomfield Hospital
Broomfield, England CM1 7ET
United KingdomSite Not Available
Queen's Hospital
Burton-upon-Trent, England DE13 0RB
United KingdomSite Not Available
Addenbrooke's Hospital
Cambridge, England CB2 2QQ
United KingdomSite Not Available
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England GL53 7AN
United KingdomSite Not Available
Royal Devon and Exeter Hospital
Exeter, England EX2 5DW
United KingdomSite Not Available
Queen Elizabeth Hospital
Gateshead, England NE9 6SX
United KingdomSite Not Available
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England GU2 7XX
United KingdomSite Not Available
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England HU8 9HE
United KingdomSite Not Available
Ipswich Hospital
Ipswich, England IP4 5PD
United KingdomSite Not Available
Airedale General Hospital
Keighley, England BD20 6TD
United KingdomSite Not Available
Leeds Cancer Centre at St. James's University Hospital
Leeds, England LS9 7TF
United KingdomSite Not Available
Guy's Hospital
London, England SE1 9RT
United KingdomSite Not Available
Hammersmith Hospital
London, England W12 OHS
United KingdomSite Not Available
St. George's Hospital
London, England SW17 0QT
United KingdomSite Not Available
University College of London Hospitals
London, England NW1 2PG
United KingdomSite Not Available
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England ME16 9QQ
United KingdomSite Not Available
Christie Hospital
Manchester, England M20 4BX
United KingdomSite Not Available
Queen Elizabeth The Queen Mother Hospital
Margate, England CT9 4AN
United KingdomSite Not Available
Clatterbridge Centre for Oncology
Merseyside, England CH63 4JY
United KingdomSite Not Available
James Cook University Hospital
Middlesbrough, England TS4 3BW
United KingdomSite Not Available
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle-Upon-Tyne, England NE4 6BE
United KingdomSite Not Available
Northampton General Hospital
Northampton, England NN1 5BD
United KingdomSite Not Available
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England HA6 2RN
United KingdomSite Not Available
Norfolk and Norwich University Hospital
Norwich, England NR4 7UY
United KingdomSite Not Available
Nottingham City Hospital
Nottingham, England NG5 1PB
United KingdomSite Not Available
Churchill Hospital
Oxford, England OX3 7LJ
United KingdomSite Not Available
Derriford Hospital
Plymouth, England PL6 8DH
United KingdomSite Not Available
Dorset Cancer Centre
Poole Dorset, England BH15 2JB
United KingdomSite Not Available
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England PO3 6AD
United KingdomSite Not Available
Cancer Research Centre at Weston Park Hospital
Sheffield, England S1O 2SJ
United KingdomSite Not Available
Royal Shrewsbury Hospital
Shrewsbury, England SY3 8XQ
United KingdomSite Not Available
Stoke Mandeville Hospital
Shrewsbury, England SY3 8XQ
United KingdomSite Not Available
Wexham Park Hospital
Slough, Berkshire, England SL2 4HL
United KingdomSite Not Available
Southampton General Hospital
Southampton, England SO16 6YD
United KingdomSite Not Available
Staffordshire General Hospital
Stafford, England ST16 3SA
United KingdomSite Not Available
Royal Marsden - Surrey
Sutton, England SM2 5PT
United KingdomSite Not Available
Great Western Hospital
Swindon, England SN3 6BB
United KingdomSite Not Available
Royal Cornwall Hospital
Truro, Cornwall, England TR1 3LJ
United KingdomSite Not Available
Yeovil District Hospital
Yeovil - Somerset, England BA21 4AT
United KingdomSite Not Available
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland BT9 7AB
United KingdomSite Not Available
Aberdeen Royal Infirmary
Aberdeen, Scotland AB25 2ZN
United KingdomSite Not Available
Ninewells Hospital
Dundee, Scotland DD1 9SY
United KingdomSite Not Available
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland EH4 2XU
United KingdomSite Not Available
Ysbyty Gwynedd
Bangor, Wales LL57 2PW
United KingdomSite Not Available
South West Wales Cancer Institute
Swansea, Wales SA2 8QA
United KingdomSite Not Available

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