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Cervical CancerPhase 2NCT02467907

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

A Phase 2 study testing Bevacizumab, Carboplatin and Paclitaxel in people with Cervical Cancer, run by Hoffmann-La Roche at 43 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Bevacizumab, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
43 sitesin 18 countries
Study dates
28 Jul 2015to 15 Jan 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

43 sites in 18 countries.

43 sites in 18 countries

Spain6 sites

  • Hospital Duran i Reynals; Oncologia

    Barcelona, 08907

  • Centro Oncologico MD Anderson International Espana

    Madrid, 28033

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

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

    Santiago de Compostela, LA Coruña, 15706

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

  • Hospital Universitario la Fe; Servicio de Oncologia

    Valencia, 46026

Other trials in Spain

Brazil4 sites

  • Oncologica Brasil S/S LTDA - EPP

    Belém, Pará, 66053-000

  • Hospital das Clinicas - UFMG

    Belo Horizonte, Minas Gerais, 31270-901

  • Instituto Nacional de Cancer - INCa; Pesquisa Clinica

    Rio de Janerio, Rio de Janeiro, 20560-120

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

Italy4 sites

  • Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

    Milan, Lombardy, 20133

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

    Milan, Lombardy, 20141

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

    Naples, Campania, 80131

  • Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica

    Rome, Lazio, 00168

Other trials in Italy

Poland4 sites

  • Bialostockie Centrum Onkologi

    Bialystok, 15-027

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

    Krakow, 31-115

  • Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie

    Poznan, 61-866

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

    Warsaw, 02-781

Other trials in Poland

Mexico3 sites

  • Instituto Nacional de Cancerologia; Oncology

    Distrito Federal, 14080

  • Consultorio de Medicina Especializada

    México, Mexico CITY (federal District), 03100

  • Centro Oncologico Estatal ISSEMYM

    Toluca, 50180

Other trials in Mexico

Bulgaria2 sites

  • Complex Oncological Center - Plovdiv, EOOD

    Plovdiv, 4004

  • MHAT Nadezhda

    Sofia, 1330

Other trials in Bulgaria

Colombia2 sites

  • Oncomedica S.A.

    Montería, 230002

  • Oncólogos de Occidente

    Pereira, 600004

Other trials in Colombia

France2 sites

  • Centre Francois Baclesse; Urologie Gynecologie

    Caen, 14076

  • Institut Gustave Roussy; Oncologie Medicale

    Villejuif, 94800

Other trials in France

Greece2 sites

  • Alexandras General Hospital of Athens; Oncology Department

    Athens, 115280

  • IASO

    Athens, 151 23

Other trials in Greece

Panama2 sites

  • Centro Oncológico de Panamá

    Panama City, 0801

  • Centro Hemato Oncologico Panama

    Panama City, 0832

Other trials in Panama

Romania2 sites

  • Centrul de Oncologie Sfantul Nectarie

    Craiova, 200347

  • Regional Institute of Oncology Iasi

    Iași, 700483

Other trials in Romania

Russia2 sites

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

    Moscow, 115478

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

    Saint Petersburg, 197022

Other trials in Russia

South Africa2 sites

  • Wits Clinical Research

    Johannesberg, 2013

  • University of Pretoria; Department of Medical Oncology

    Pretoria, 0002

Other trials in South Africa

Turkey (Türkiye)2 sites

  • Ankara Baskent University Medicine Faculty; Gynaecology

    Ankara, 06500

  • Istanbul Uni of Medicine Faculty; Oncology Dept

    Istanbul, 34390

Other trials in Turkey (Türkiye)

Argentina1 site

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

Other trials in Argentina

Costa Rica1 site

  • Clinica CIMCA

    San José, 10103

Other trials in Costa Rica

Portugal1 site

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

Serbia1 site

  • Institute for Onc/Rad Serbia

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: 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.

Conditions
Cervical Cancer
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin, RO4876646

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

  • CarboplatinDrug

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

  • PaclitaxelDrug

    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

Study groups in NCT02467907
Study groupRoleWhat they receive
Bevacizumab in Combination with Carboplatin and PaclitaxelExperimentalAdministration 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.
Receives: Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline up to 24 months

  2. Percentage of Participants with GI-Vaginal Fistula Events by Grade According to NCI-CTCAE Version 4.0

    Measured: Baseline up to 24 months

  3. Percentage of Participants with GU Fistula Events by Grade According to NCI-CTCAE Version 4.0

    Measured: Baseline up to 24 months

Secondary outcomes (17)

  1. Time to First GI Perforation/Fistula

    Measured: Baseline up to 24 months

  2. Time to First GI-Vaginal Fistula

    Measured: Baseline up to 24 months

  3. Time to First GU Fistula

    Measured: Baseline up to 24 months

  4. Dose Intensity (Ratio of Actual Dose Administered Versus Intended Dose) for Bevacizumab During the Treatment Period

    Measured: Baseline up to 24 months

  5. Dose Intensity (Ratio of Actual Dose Administered Versus Intended Dose) for Carboplatin During the Treatment Period

    Measured: Baseline up to 24 months

  6. Dose Intensity (Ratio of Actual Dose Administered Versus Intended Dose) for Paclitaxel During the Treatment Period

    Measured: Baseline up to 24 months

  7. Duration of Treatment for Bevacizumab

    Measured: Baseline up to 24 months

  8. Duration of Treatment for Carboplatin

    Measured: Baseline up to 24 months

  9. Duration of Treatment for Paclitaxel

    Measured: Baseline up to 24 months

  10. Percentage of Participants with Adverse Events (AEs)

    Measured: Baseline up to 24 months

  11. Percentage of Participants with Serious Adverse Events (SAEs)

    Measured: Baseline up to 24 months

  12. Percentage of Participants with Adverse Events of Special Interest (AESIs)

    Measured: Baseline up to 24 months

  13. Percentage of Participants with AEs Leading to Treatment Interruption or Permanent discontinuation

    Measured: Baseline up to 24 months

  14. Percentage of Deaths Causally Related to Treatment

    Measured: Baseline up to 24 months

  15. Progression-Free Survival (PFS) According to Response Evaluation Criteria for Solid Tumors (RECIST) Version 1.1

    Measured: Baseline up to 24 months

  16. Overall Survival (OS)

    Measured: Baseline up to 24 months

  17. Percentage of Participants with a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.1

    Measured: Baseline up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2015 (estimated)
  2. Study start28 Jul 2015
  3. Primary completion31 Dec 2018
  4. Study completion15 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02467907
Sponsor's protocol ID
MO29594
Other IDs
2014-005491-28, 2014
Status last verified
May 2019
First submitted
21 May 2015
Last updated
3 Jun 2019
Results posted
No

Publications

  • 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.

    PubMed 32763109

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Carboplatin and Paclitaxel in people with Cervical Cancer, run by Hoffmann-La Roche at 43 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Spain, Brazil, Italy, Poland, Mexico and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02467907, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.

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