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

May 30, 2019 updated by: Hoffmann-La Roche

A Multicenter Open-Label Single-Arm Phase II Study Evaluating the Safety and Efficacy of Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Metastatic, Recurrent or Persistent Cervical Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral (Cori)
  • Brazil
    • MG
      • Belo Horizonte, MG, Brazil, 31270-901
        • Hospital das Clinicas - UFMG
    • PA
      • Belem, PA, Brazil, 66053-000
        • Oncologica Brasil S/S LTDA - EPP
    • RJ
      • Rio De Janerio, RJ, Brazil, 20560-120
        • Instituto Nacional de Cancer - INCa; Pesquisa Clinica
    • SP
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • Complex Oncological Center - Plovdiv, EOOD
      • Sofia, Bulgaria, 1330
        • MHAT Nadezhda
  • Colombia
      • Monteria, Colombia, 230002
        • Oncomedica S.A.
      • Pereira, Colombia, 600004
        • Oncólogos de Occidente
  • Costa Rica
      • San Jose, Costa Rica, 10103
        • Clinica CIMCA
  • France
      • Caen, France, 14076
        • Centre Francois Baclesse; Urologie Gynecologie
      • Villejuif, France, 94800
        • Institut Gustave Roussy; Oncologie Medicale
  • Greece
      • Athens, Greece, 115280
        • Alexandras General Hospital of Athens; Oncology Department
      • Athens, Greece, 151 23
        • IASO
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica
    • Lombardia
      • Milano, Lombardia, Italy, 20141
        • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
      • Milano, Lombardia, Italy, 20133
        • Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
  • Mexico
      • Distrito Federal, Mexico, 14080
        • Instituto Nacional de Cancerologia; Oncology
      • Toluca, Mexico, 50180
        • Centro Oncologico Estatal ISSEMYM
    • Mexico CITY (federal District)
      • Mexico, Mexico CITY (federal District), Mexico, 03100
        • Consultorio de Medicina Especializada
  • Panama
      • Panama, Panama, 0832
        • Centro Hemato Oncologico Panama
      • Panama, Panama, 0801
        • Centro Oncológico de Panamá
  • Poland
      • Bialystok, Poland, 15-027
        • Bialostockie Centrum Onkologi
      • Krakow, Poland, 31-115
        • Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej
      • Poznan, Poland, 61-866
        • Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie
      • Warszawa, Poland, 02-781
        • Centrum Onkologii - Instytut M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej
  • Portugal
      • Porto, Portugal, 4200-072
        • IPO do Porto; Servico de Oncologia Medica
  • Romania
      • Craiova, Romania, 200347
        • Centrul de Oncologie Sfantul Nectarie
      • Iasi, Romania, 700483
        • Regional Institute of Oncology Iasi
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
      • Saint-Petersburg, Russian Federation, 197022
        • St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute for Onc/Rad Serbia
  • South Africa
      • Johannesberg, South Africa, 2013
        • Wits Clinical Research
      • Pretoria, South Africa, 0002
        • University of Pretoria; Department of Medical Oncology
  • Spain
      • Barcelona, Spain, 08907
        • Hospital Duran i Reynals; Oncologia
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz; Servicio de Oncologia
      • Madrid, Spain, 28033
        • Centro Oncologico MD Anderson International Espana
      • Valencia, Spain, 46009
        • Instituto Valenciano Oncologia; Oncologia Medica
      • Valencia, Spain, 46026
        • Hospital Universitario la Fe; Servicio de Oncologia
    • LA Coruña
      • Santiago de Compostela, LA Coruña, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
  • Turkey
      • Ankara, Turkey, 06500
        • Ankara Baskent University Medicine Faculty; Gynaecology
      • Istanbul, Turkey, 34390
        • Istanbul Uni of Medicine Faculty; Oncology Dept

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Bevacizumab
Intravenous (i.v.) administration of 15 mg/kg bevacizumab once every 3 weeks
Other Names:
  • Avastin, RO4876646
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants with GI Perforation/Fistula Events by Grade According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Percentage of Participants with GI-Vaginal Fistula Events by Grade According to NCI-CTCAE Version 4.0
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Percentage of Participants with GU Fistula Events by Grade According to NCI-CTCAE Version 4.0
Time Frame: Baseline up to 24 months
Baseline up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to First GI Perforation/Fistula
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Time to First GI-Vaginal Fistula
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Time to First GU Fistula
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Dose Intensity (Ratio of Actual Dose Administered Versus Intended Dose) for Bevacizumab During the Treatment Period
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Dose Intensity (Ratio of Actual Dose Administered Versus Intended Dose) for Carboplatin During the Treatment Period
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Dose Intensity (Ratio of Actual Dose Administered Versus Intended Dose) for Paclitaxel During the Treatment Period
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Duration of Treatment for Bevacizumab
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Duration of Treatment for Carboplatin
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Duration of Treatment for Paclitaxel
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Percentage of Participants with Adverse Events (AEs)
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Percentage of Participants with Serious Adverse Events (SAEs)
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Percentage of Participants with AEs Leading to Treatment Interruption or Permanent discontinuation
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Percentage of Deaths Causally Related to Treatment
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Progression-Free Survival (PFS) According to Response Evaluation Criteria for Solid Tumors (RECIST) Version 1.1
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Overall Survival (OS)
Time Frame: Baseline up to 24 months
Baseline up to 24 months
Percentage of Participants with a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.1
Time Frame: Baseline up to 24 months
Baseline up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MO29594
  • 2014-005491-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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