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

NCT ID: NCT02467907

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-28
• Study Completion Date: 2019-01-15

Brief 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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab in Combination with Carboplatin and Paclitaxel

Administration of bevacizumab, carboplatin and paclitaxel once every 3 weeks, for at least 6 cycles, until disease progression (as assessed by the investigator), unacceptable toxicity, physician or participant decision or withdrawal of consent. If either chemotherapy or bevacizumab is discontinued, the participant may continue to receive the other ongoing therapy.

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Intravenous (i.v.) administration of 15 mg/kg bevacizumab once every 3 weeks

Carboplatin

Intervention Type: DRUG

Administration of carboplatin at 5 milligrams per milliliter\*minute (mg/mL\*min) on Day 1 every 3 weeks for at least 6 cycles

Paclitaxel

Intervention Type: DRUG

Administration of paclitaxel at a dose of 175 milligrams per square meter (mg/m\^2) on Day 1 every 3 weeks for at least 6 cycles

Interventions

Bevacizumab

Intravenous (i.v.) administration of 15 mg/kg bevacizumab once every 3 weeks

Intervention Type: DRUG

Carboplatin

Administration of carboplatin at 5 milligrams per milliliter\*minute (mg/mL\*min) on Day 1 every 3 weeks for at least 6 cycles

Intervention Type: DRUG

Paclitaxel

Administration of paclitaxel at a dose of 175 milligrams per square meter (mg/m\^2) on Day 1 every 3 weeks for at least 6 cycles

Intervention Type: DRUG

Other Intervention Names

Avastin, RO4876646

Eligibility Criteria

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 remain abstinent or use single or combined contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 6 months after the last dose of study drug
• Distant metastatic, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy
• Either measurable or non-measurable disease. If disease is non-measurable or limited to the radiation field, a biopsy or fine-needle aspiration is required to confirm malignancy
• Eligible for carboplatin and paclitaxel chemotherapy in accordance with local standards 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 Criteria

• Pregnant or lactating
• History of other malignancy within 5 years before screening, except for non-melanoma skin carcinoma
• Ongoing disease involving the bladder or rectum at screening/baseline. In participants with pelvic disease, absence of tumor in the bladder or rectal mucosa must be demonstrated by magnetic resonance imaging (MRI) (preferred method, or endoscopy/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. Prior adjuvant or neoadjuvant chemotherapy for Stage I-IVA disease (i.e. for non-metastatic disease) 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 of any of the study drugs, may interfere with the planned treatment, affects participant compliance or puts the participant at high risk for treatment-related complications
• Treatment with another investigational agent within 28 days or 2 investigational agent half-lives before first study dose
• Major surgical procedure, open biopsy or significant traumatic injury within 28 days before the first dose of bevacizumab or anticipation of the need for major surgery during 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 ovary cell products or other recombinant human or humanized antibodies to any planned chemotherapy
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Centro Oncologico Riojano Integral (CORI)

La Rioja, , Argentina

Hospital das Clinicas - UFMG

Belo Horizonte, Minas Gerais, Brazil

Oncologica Brasil S/S LTDA - EPP

Belém, Pará, Brazil

Instituto Nacional de Cancer - INCa; Pesquisa Clinica

Rio de Janerio, Rio de Janeiro, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Complex Oncological Center - Plovdiv, EOOD

Plovdiv, , Bulgaria

MHAT Nadezhda

Sofia, , Bulgaria

Oncomedica S.A.

Montería, , Colombia

Oncólogos de Occidente

Pereira, , Colombia

Clinica CIMCA

San José, , Costa Rica

Centre Francois Baclesse; Urologie Gynecologie

Caen, , France

Institut Gustave Roussy; Oncologie Medicale

Villejuif, , France

Alexandras General Hospital of Athens; Oncology Department

Athens, , Greece

IASO

Athens, , Greece

Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica

Napoli, Campania, Italy

Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica

Rome, Lazio, Italy

Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

Milan, Lombardy, Italy

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

Milan, Lombardy, Italy

Consultorio de Medicina Especializada

México, Mexico CITY (federal District), Mexico

Instituto Nacional de Cancerologia; Oncology

Distrito Federal, , Mexico

Centro Oncologico Estatal ISSEMYM

Toluca, , Mexico

Centro Oncológico de Panamá

Panama City, , Panama

Centro Hemato Oncologico Panama

Panama City, , Panama

Bialostockie Centrum Onkologi

Bialystok, , Poland

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

Krakow, , Poland

Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie

Poznan, , Poland

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

Warsaw, , Poland

IPO do Porto; Servico de Oncologia Medica

Porto, , Portugal

Centrul de Oncologie Sfantul Nectarie

Craiova, , Romania

Regional Institute of Oncology Iasi

Iași, , Romania

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

Moscow, , Russia

St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary

Saint Petersburg, , Russia

Institute for Onc/Rad Serbia

Belgrade, , Serbia

Wits Clinical Research

Johannesberg, , South Africa

University of Pretoria; Department of Medical Oncology

Pretoria, , South Africa

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

Santiago de Compostela, LA Coruña, Spain

Hospital Duran i Reynals; Oncologia

Barcelona, , Spain

Centro Oncologico MD Anderson International Espana

Madrid, , Spain

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, , Spain

Instituto Valenciano Oncologia; Oncologia Medica

Valencia, , Spain

Hospital Universitario la Fe; Servicio de Oncologia

Valencia, , Spain

Ankara Baskent University Medicine Faculty; Gynaecology

Ankara, , Turkey (Türkiye)

Istanbul Uni of Medicine Faculty; Oncology Dept

Istanbul, , Turkey (Türkiye)

Countries

Argentina; Brazil; Bulgaria; Colombia; Costa Rica; France; Greece; Italy; Mexico; Panama; Poland; Portugal; Romania; Russia; Serbia; South Africa; Spain; Turkey (Türkiye)

References

Redondo A, Colombo N, McCormack M, Dreosti L, Nogueira-Rodrigues A, Scambia G, Lorusso D, Joly F, Schenker M, Ruff P, Estevez-Diz M, Irahara N, Donica M, Gonzalez-Martin A. Primary results from CECILIA, a global single-arm phase II study evaluating bevacizumab, carboplatin and paclitaxel for advanced cervical cancer. Gynecol Oncol. 2020 Oct;159(1):142-149. doi: 10.1016/j.ygyno.2020.07.026. Epub 2020 Aug 4.

Reference Type: DERIVED

PMID: 32763109 (View on PubMed)

Other Identifiers

2014-005491-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MO29594

Identifier Type: -

Identifier Source: org_study_id