Safety and Efficacy of Bevacizumab in Combination With Carboplatin and Paclitaxel for Metastatic, Recurrent or Persistent Cervical Cancer

Last updated: May 30, 2019
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

2

Condition

Uterine Disorders

Cervical Cancer

Pelvic Cancer

Treatment

N/A

Clinical Study ID

NCT02467907
MO29594
2014-005491-28
  • Ages > 18
  • Female

Study Summary

This study is to assess safety as defined by the frequency and severity of gastrointestinal (GI) perforation/fistula, GI-vaginal fistula and genitourinary (GU) fistula in participants treated with bevacizumab 15 milligrams per kilogram (mg/kg) in combination with paclitaxel and carboplatin, all repeated every 3 weeks, for recurrent, persistent or metastatic cervical cancer. In addition, this study will include evaluation of the overall safety profile of bevacizumab in combination with paclitaxel and carboplatin in this setting, assessment of GI perforation/fistula, GI-vaginal fistula and GU fistula events over time, and evaluation of efficacy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

  • Life expectancy greater than or equal to (>=3) months

  • For women who are not postmenopausal or surgically sterile, agreement to remainabstinent or use single or combined contraceptive methods that result in a failurerate of less than (<) 1 percent (%) per year during the treatment period and for atleast 6 months after the last dose of study drug

  • Distant metastatic, recurrent or persistent squamous cell carcinoma, adenosquamouscarcinoma or adenocarcinoma of the cervix that is not amenable to curative treatmentwith surgery and/or radiation therapy

  • Either measurable or non-measurable disease. If disease is non-measurable or limitedto the radiation field, a biopsy or fine-needle aspiration is required to confirmmalignancy

  • Eligible for carboplatin and paclitaxel chemotherapy in accordance with localstandards of care

  • Adequate hematological, renal and hepatic function

  • Normal blood coagulation parameters

  • Recovered (to Grade less than or equal to [<=] 1) from the effects of prior surgery,radiation therapy or chemoradiotherapy

Exclusion

Exclusion Criteria:

  • Pregnant or lactating

  • History of other malignancy within 5 years before screening, except for non-melanomaskin carcinoma

  • Ongoing disease involving the bladder or rectum at screening/baseline. In participantswith pelvic disease, absence of tumor in the bladder or rectal mucosa must bedemonstrated by magnetic resonance imaging (MRI) (preferred method, orendoscopy/cystoscopy if MRI is not easily accessible) within 28 days before enrolment

  • Evidence of abdominal free air

  • Bilateral hydronephrosis

  • Untreated central nervous system (CNS) metastases

  • Prior chemotherapy for recurrent, persistent or metastatic cervical cancer. Prioradjuvant or neoadjuvant chemotherapy for Stage I-IVA disease (i.e. for non-metastaticdisease) is permitted if completed greater than (>) 6 months before first study dose

  • Prior chemoradiation within the 3 months preceding first study dose

  • Prior radiotherapy delivered using cobalt

  • Prior or current bevacizumab or other anti-angiogenic treatment

  • Requirement for treatment with any medicinal product that contraindicates the use ofany of the study drugs, may interfere with the planned treatment, affects participantcompliance or puts the participant at high risk for treatment-related complications

  • Treatment with another investigational agent within 28 days or 2 investigational agenthalf-lives before first study dose

  • Major surgical procedure, open biopsy or significant traumatic injury within 28 daysbefore the first dose of bevacizumab or anticipation of the need for major surgeryduring the course of study treatment

  • Minor surgical procedure within 2 days before the first dose of study drug

  • Any prior history of fistula or GI perforation

  • Known hypersensitivity to bevacizumab or any of its excipients, Chinese hamster ovarycell products or other recombinant human or humanized antibodies to any plannedchemotherapy

  • Active GI bleeding or ulcer

  • Uncontrolled hypertension

  • Clinically significant active cardiovascular disease

  • National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)Version 4.0, Grade greater than or equal to (>=) 2 peripheral vascular disease

Study Design

Total Participants: 152
Study Start date:
July 28, 2015
Estimated Completion Date:
January 15, 2019

Connect with a study center

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE
    Argentina

    Site Not Available

  • COIBA

    Provincia de Buenos Aires, B1884BBF
    Argentina

    Site Not Available

  • Hospital das Clinicas - UFMG

    Belo Horizonte, MG 31270-901
    Brazil

    Site Not Available

  • Oncologica Brasil S/S LTDA - EPP

    Belem, PA 66053-000
    Brazil

    Site Not Available

  • Instituto Nacional de Cancer - INCa; Pesquisa Clinica

    Rio De Janerio, RJ 20560-120
    Brazil

    Site Not Available

  • Instituto Nacional de Cancer - INCa; Pesquisa Clinica

    Rio de Janeiro, RJ 20230-130
    Brazil

    Site Not Available

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    Sao Paulo, SP 01246-000
    Brazil

    Site Not Available

  • Complex Oncological Center - Plovdiv, EOOD

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • MHAT Nadezhda

    Sofia, 1330
    Bulgaria

    Site Not Available

  • Inst. Nacional de Cancerologia; Clinica de Seno

    Bogota,
    Colombia

    Site Not Available

  • Oncomedica S.A.

    Monteria, 230002
    Colombia

    Site Not Available

  • Oncólogos de Occidente

    Pereira, 600004
    Colombia

    Site Not Available

  • Clinica CIMCA

    San Jose, 10103
    Costa Rica

    Site Not Available

  • Centre Francois Baclesse; Urologie Gynecologie

    Caen, 14076
    France

    Site Not Available

  • Institut Gustave Roussy; Oncologie Medicale

    Villejuif, 94800
    France

    Site Not Available

  • Alexandras General Hospital of Athens; Oncology Department

    Athens, 115280
    Greece

    Site Not Available

  • IASO

    Athens, 151 23
    Greece

    Site Not Available

  • Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

    Milano, Lombardia 20141
    Italy

    Site Not Available

  • Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

    Milano, Lombardia 20133
    Italy

    Site Not Available

  • Consultorio de Medicina Especializada

    Mexico, Mexico CITY (federal District) 03100
    Mexico

    Site Not Available

  • Instituto Nacional de Cancerologia; Oncology

    Distrito Federal, 14080
    Mexico

    Site Not Available

  • Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

    Mexico City, 03100
    Mexico

    Site Not Available

  • Centro Oncologico Estatal ISSEMYM

    Toluca, 50180
    Mexico

    Site Not Available

  • Centro Hemato Oncologico Panama

    Panama, 0832
    Panama

    Site Not Available

  • Centro Oncológico de Panamá

    Panama, 0801
    Panama

    Site Not Available

  • Centro Hemato Oncologico Paitilla

    Panama City, 083200752
    Panama

    Site Not Available

  • Bialostockie Centrum Onkologi

    Bialystok, 15-027
    Poland

    Site Not Available

  • Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej

    Krakow, 31-115
    Poland

    Site Not Available

  • Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie

    Poznan, 61-866
    Poland

    Site Not Available

  • Centrum Onkologii - Instytut M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej

    Warszawa, 02-781
    Poland

    Site Not Available

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072
    Portugal

    Site Not Available

  • empty

    Bucharest, 011191
    Romania

    Site Not Available

  • Centrul de Oncologie Sfantul Nectarie

    Craiova, 200347
    Romania

    Site Not Available

  • Regional Institute of Oncology Iasi

    Iasi, 700483
    Romania

    Site Not Available

  • Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

    Moscow, 115478
    Russian Federation

    Site Not Available

  • St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary

    Saint-Petersburg, 197022
    Russian Federation

    Site Not Available

  • Institute for Onc/Rad Serbia

    Belgrade, 11000
    Serbia

    Site Not Available

  • Wits Clinical Research

    Johannesberg, 2013
    South Africa

    Site Not Available

  • Wits Clinical Research

    Johannesburg, 2193
    South Africa

    Site Not Available

  • empty

    Pietermaritzburg, 3200
    South Africa

    Site Not Available

  • University of Pretoria; Department of Medical Oncology

    Pretoria, 0002
    South Africa

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

    Santiago de Compostela, LA Coruña 15706
    Spain

    Site Not Available

  • Hospital Duran i Reynals; Oncologia

    Barcelona, 08907
    Spain

    Site Not Available

  • Centro Oncologico MD Anderson International Espana

    Madrid, 28033
    Spain

    Site Not Available

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario la Fe; Servicio de Oncologia

    Valencia, 46026
    Spain

    Site Not Available

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009
    Spain

    Site Not Available

  • Ankara Baskent University Medicine Faculty; Gynaecology

    Ankara, 06500
    Turkey

    Site Not Available

  • Istanbul Uni of Medicine Faculty; Oncology Dept

    Istanbul, 34390
    Turkey

    Site Not Available

  • Ege Uni Medical Faculty Hospital; Oncology Dept

    Izmir, 35100
    Turkey

    Site Not Available

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