Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Newly Diagnosed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

NCT00483782 | Completed Phase 3

• 7 other identifiers: MREC-ICON7CDR0000548777EUDRACT-2005-003929-22ISRCTN91273375ROCHE-MREC-ICON7EU-20730MREC-06/MRE02/52
• Study Type: interventional
• Target: 1,520
• Locations: 5 countries
• Sites: 142

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

stage IV ovarian epithelial cancer; Brenner tumor; ovarian carcinosarcoma; ovarian clear cell cystadenocarcinoma; ovarian endometrioid adenocarcinoma; ovarian mixed epithelial carcinoma; ovarian mucinous cystadenocarcinoma; ovarian serous cystadenocarcinoma; ovarian undifferentiated adenocarcinoma; stage IA ovarian epithelial cancer; stage IB ovarian epithelial cancer; stage IC ovarian epithelial cancer; stage IIA ovarian epithelial cancer; stage IIB ovarian epithelial cancer; stage IIC ovarian epithelial cancer; stage IIIA ovarian epithelial cancer; stage IIIB ovarian epithelial cancer; stage IIIC ovarian epithelial cancer; stage IA fallopian tube cancer; stage IB fallopian tube cancer; stage IC fallopian tube cancer; stage IIA fallopian tube cancer; stage IIB fallopian tube cancer; stage IIC fallopian tube cancer; stage IIIA fallopian tube cancer; stage IIIB fallopian tube cancer; stage IIIC fallopian tube cancer; stage IV fallopian tube cancer; stage IA primary peritoneal cavity cancer; stage IB primary peritoneal cavity cancer; stage IC primary peritoneal cavity cancer; stage IIA primary peritoneal cavity cancer; stage IIB primary peritoneal cavity cancer; stage IIC primary peritoneal cavity cancer; stage IIIA primary peritoneal cavity cancer; stage IIIB primary peritoneal cavity cancer; stage IIIC primary peritoneal cavity cancer; stage IV primary peritoneal cavity cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (7)

• Duration of overall survival

• Objective response rate

• Duration of response

• Biological progression-free interval as measured by increasing CA 125 levels

• Safety as measured by NCI CTAE version 3.0

Interventions

bevacizumab BIOLOGICAL

carboplatin DRUG

paclitaxel DRUG

questionnaire administration OTHER

study of socioeconomic and demographic variables OTHER

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical Research Council: lead

Study Sites (142)

Cancer Therapy Centre at Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Prince of Wales Private Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Newcastle Mater Misericordiae Hospital

Waratah, New South Wales, 2298, Australia

Location

Westmead Institute for Cancer Research at Westmead Hospital

Wentworthville, New South Wales, 2145, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Mater Adult Hospital

South Brisbane, Queensland, 4101, Australia

Location

Royal Adelaide Hospital Cancer Centre

Adelaide, South Australia, 5000, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Royal Women's Hospital

Carlton, Victoria, 3053, Australia

Location

Mercy Hospital for Women

East Melbourne, Victoria, 3002, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Murray Valley Private Hospital and Cancer Treatment Centre

Wodonga, Victoria, 3690, Australia

Location

Sir Charles Gairdner Hospital - Perth

Perth, Western Australia, 6009, Australia

Location

Centre Paul Papin

Angers, 49100, France

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

Location

Clinique Tivoli

Bordeaux, F-33000, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

CHU de Grenoble - Hopital de la Tronche

Grenoble, 38043, France

Location

Institut Prive de Cancerologie

Grenoble, 38100, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre D'Oncologie De Gentilly

Nancy, 54100, France

Location

Centre Catherine de Sienne

Nantes, 02, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Institut Curie Hopital

Paris, 75020, France

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Hopital Cochin

Paris, 75674, France

Location

Hopital Tenon

Paris, 75970, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Hopital Universitaire Hautepierre

Strasbourg, 67098, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Evang. Waldkrankenhaus Spandau

Berlin, 13589, Germany

Location

Charite University Hospital - Campus Virchow Klinikum

Berlin, D-13353, Germany

Location

Klinikum Bremen-Mitte

Bremen, D-28205, Germany

Location

Praxis Dres. F.& G. Doering

Bremen, D-28205, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, D-09116, Germany

Location

Universitatsklinikum Carl Gustav Carus

Dresden, D-01307, Germany

Location

Kreiskrankenhaus

Ebersberg, D-85560, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Elisabeth-Krankenhaus

Essen, D-45138, Germany

Location

Staedtische Kliniken Esslingen

Esslingen am Neckar, D-73730, Germany

Location

Onkologie Bethanien

Frankfurt, D-60389, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Staedtische Kliniken Frankfurt am Main - Hoechst

Frankfurt, D-65929, Germany

Location

Universitaetsfrauenklinik Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

Franziskus Hospital Hardenberg

Georgsmarienhütte, D-49124, Germany

Location

Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

Greifswald, D-17487, Germany

Location

Universitaetsklinikum Halle

Halle, D-06097, Germany

Location

Henriettenstiftung Frauenklinik

Hanover, D-30559, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

St. Vincentius - Kliniken

Karlsruhe, D-76137, Germany

Location

Klinikum Kassel

Kassel, D-34125, Germany

Location

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24105, Germany

Location

Kreiskrankenhaus Lahr

Lahr, D-77993, Germany

Location

Kreiskrankenhaus Leonberg - Frauenklinik

Leonberg, D-71229, Germany

Location

Asklepios Klinik Lich

Lich, D-35423, Germany

Location

St. Vincenz Hospital Limburg

Limburg, D-65549, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, D-23538, Germany

Location

Staedtisches Klinikum Lueneburg

Lüneburg, D-21339, Germany

Location

Klinik St. Marienstift Magdeburg

Magdeburg, D-39110, Germany

Location

St. Vincenz und Elisabeth Hospital

Mainz, 55131, Germany

Location

Universitaetsklinikum Giessen und Marburg GmbH - Marburg

Marburg, D-35043, Germany

Location

Klinikum Minden

Minden, D-32423, Germany

Location

I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen

Munich, D-80337, Germany

Location

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Staedtisches Klinikum Neunkirchen gGmbH

Neunkirchen, D-66538, Germany

Location

Lukaskrankenhaus Neuss

Neuss, D-41464, Germany

Location

Klinikum Offenback GmbH

Offenbach, D-63069, Germany

Location

Saint Vincenz-Krankenhaus Paderborn

Paderborn, 33098, Germany

Location

Klinikum Dorothea Christiane Erxleben - Quedlingburg

Quedlinburg, D-06484, Germany

Location

Krankenhaus St. Elisabeth - Ravensburg

Ravensburg, D-88212, Germany

Location

St. Marien - Krankenhaus Siegen GMBH

Siegen, D-57072, Germany

Location

Kliniken Landkreis Sigmaringen GMBH

Sigmaringen, D-72488, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

Marienhospital Stuttgart

Stuttgart, D-70199, Germany

Location

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, D-89081, Germany

Location

Dr. Horst-Schmidt-Kliniken

Wiesbaden, D-65199, Germany

Location

Marien-Hospital Witten

Witten, 58452, Germany

Location

Klinikum der Stadt Wolfsburg

Wolfsburg, D-38440, Germany

Location

Praxis Fuer Haemotologie Und Internistischer Onkologie

Wuppertal, 42105, Germany

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

North Devon District Hospital

Barnstaple, England, EX31 4JB, United Kingdom

Location

Broomfield Hospital

Broomfield, England, CM1 7ET, United Kingdom

Location

Queen's Hospital

Burton-on-Trent, England, DE13 0RB, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Queen Elizabeth Hospital

Gateshead, England, NE9 6SX, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 7XX, United Kingdom

Location

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, HU8 9HE, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Airedale General Hospital

Keighley, England, BD20 6TD, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

University College of London Hospitals

London, England, NW1 2PG, United Kingdom

Location

Guy's Hospital

London, England, SE1 9RT, United Kingdom

Location

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

Hammersmith Hospital

London, England, W12 OHS, United Kingdom

Location

Mid Kent Oncology Centre at Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Queen Elizabeth The Queen Mother Hospital

Margate, England, CT9 4AN, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Northampton General Hospital

Northampton, England, NN1 5BD, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

Location

Churchill Hospital

Oxford, England, OX3 7LJ, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Dorset Cancer Centre

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Portsmouth Oncology Centre at Saint Mary's Hospital

Portsmouth Hants, England, PO3 6AD, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, England, SY3 8XQ, United Kingdom

Location

Stoke Mandeville Hospital

Shrewsbury, England, SY3 8XQ, United Kingdom

Location

Wexham Park Hospital

Slough, Berkshire, England, SL2 4HL, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Staffordshire General Hospital

Stafford, England, ST16 3SA, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Great Western Hospital

Swindon, England, SN3 6BB, United Kingdom

Location

Royal Cornwall Hospital

Truro, Cornwall, England, TR1 3LJ, United Kingdom

Location

Yeovil District Hospital

Yeovil - Somerset, England, BA21 4AT, United Kingdom

Location

Centre for Cancer Research and Cell Biology at Queen's University Belfast

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

South West Wales Cancer Institute

Swansea, Wales, SA2 8QA, United Kingdom

Location

Related Publications (4)

• Dhillon S. Bevacizumab combination therapy: for the first-line treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Drugs. 2012 May 7;72(7):917-30. doi: 10.2165/11208940-000000000-00000.

  PMID: 22515620 BACKGROUND

• Perren TJ, Swart AM, Pfisterer J, Ledermann JA, Pujade-Lauraine E, Kristensen G, Carey MS, Beale P, Cervantes A, Kurzeder C, du Bois A, Sehouli J, Kimmig R, Stahle A, Collinson F, Essapen S, Gourley C, Lortholary A, Selle F, Mirza MR, Leminen A, Plante M, Stark D, Qian W, Parmar MK, Oza AM; ICON7 Investigators. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2484-96. doi: 10.1056/NEJMoa1103799.

  PMID: 22204725 RESULT

• Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

  PMID: 37185961 DERIVED

• Vaughan S, Coward JI, Bast RC Jr, Berchuck A, Berek JS, Brenton JD, Coukos G, Crum CC, Drapkin R, Etemadmoghadam D, Friedlander M, Gabra H, Kaye SB, Lord CJ, Lengyel E, Levine DA, McNeish IA, Menon U, Mills GB, Nephew KP, Oza AM, Sood AK, Stronach EA, Walczak H, Bowtell DD, Balkwill FR. Rethinking ovarian cancer: recommendations for improving outcomes. Nat Rev Cancer. 2011 Sep 23;11(10):719-25. doi: 10.1038/nrc3144.

  PMID: 21941283 DERIVED

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Brenner Tumor

Interventions

Bevacizumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Tim J. Perren, MD

  Leeds Cancer Centre at St. James's University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 7, 2007
• Study Start: April 1, 2006
• Last Updated: August 12, 2013

Record last verified: 2012-04

Locations

FR (29); NO (1); GB (46); AU (16); DE (50)