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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005491-28 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab in Combination with Carboplatin and Paclitaxel | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Intravenous (i.v.) administration of 15 mg/kg bevacizumab once every 3 weeks |
|
| Measure | Description | 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 | Baseline up to 24 months | |
| Percentage of Participants with GI-Vaginal Fistula Events by Grade According to NCI-CTCAE Version 4.0 | Baseline up to 24 months | |
| Percentage of Participants with GU Fistula Events by Grade According to NCI-CTCAE Version 4.0 | Baseline up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First GI Perforation/Fistula | Baseline up to 24 months | |
| Time to First GI-Vaginal Fistula | Baseline up to 24 months | |
| Time to First GU Fistula |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Oncologico Riojano Integral (CORI) | La Rioja | F5300COE | Argentina | |||
| Hospital das Clinicas - UFMG |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32763109 | Derived | 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. |
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| Carboplatin | 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 | 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 |
|
| Baseline up to 24 months |
| Dose Intensity (Ratio of Actual Dose Administered Versus Intended Dose) for Bevacizumab During the Treatment Period | Baseline up to 24 months |
| Dose Intensity (Ratio of Actual Dose Administered Versus Intended Dose) for Carboplatin During the Treatment Period | Baseline up to 24 months |
| Dose Intensity (Ratio of Actual Dose Administered Versus Intended Dose) for Paclitaxel During the Treatment Period | Baseline up to 24 months |
| Duration of Treatment for Bevacizumab | Baseline up to 24 months |
| Duration of Treatment for Carboplatin | Baseline up to 24 months |
| Duration of Treatment for Paclitaxel | Baseline up to 24 months |
| Percentage of Participants with Adverse Events (AEs) | Baseline up to 24 months |
| Percentage of Participants with Serious Adverse Events (SAEs) | Baseline up to 24 months |
| Percentage of Participants with Adverse Events of Special Interest (AESIs) | Baseline up to 24 months |
| Percentage of Participants with AEs Leading to Treatment Interruption or Permanent discontinuation | Baseline up to 24 months |
| Percentage of Deaths Causally Related to Treatment | Baseline up to 24 months |
| Progression-Free Survival (PFS) According to Response Evaluation Criteria for Solid Tumors (RECIST) Version 1.1 | Baseline up to 24 months |
| Overall Survival (OS) | 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 | Baseline up to 24 months |
| Belo Horizonte |
| Minas Gerais |
| 31270-901 |
| Brazil |
| Oncologica Brasil S/S LTDA - EPP | Belém | Pará | 66053-000 | Brazil |
| Instituto Nacional de Cancer - INCa; Pesquisa Clinica | Rio de Janerio | Rio de Janeiro | 20560-120 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Complex Oncological Center - Plovdiv, EOOD | Plovdiv | 4004 | Bulgaria |
| MHAT Nadezhda | Sofia | 1330 | Bulgaria |
| Oncomedica S.A. | Montería | 230002 | Colombia |
| Oncólogos de Occidente | Pereira | 600004 | Colombia |
| Clinica CIMCA | San José | 10103 | Costa Rica |
| Centre Francois Baclesse; Urologie Gynecologie | Caen | 14076 | France |
| Institut Gustave Roussy; Oncologie Medicale | Villejuif | 94800 | France |
| Alexandras General Hospital of Athens; Oncology Department | Athens | 115280 | Greece |
| IASO | Athens | 151 23 | Greece |
| Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica | Naples | Campania | 80131 | Italy |
| Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica | Rome | Lazio | 00168 | Italy |
| Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica | Milan | Lombardy | 20133 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica | Milan | Lombardy | 20141 | Italy |
| Consultorio de Medicina Especializada | México | Mexico CITY (federal District) | 03100 | Mexico |
| Instituto Nacional de Cancerologia; Oncology | Distrito Federal | 14080 | Mexico |
| Centro Oncologico Estatal ISSEMYM | Toluca | 50180 | Mexico |
| Centro Oncológico de Panamá | Panama City | 0801 | Panama |
| Centro Hemato Oncologico Panama | Panama City | 0832 | Panama |
| Bialostockie Centrum Onkologi | Bialystok | 15-027 | Poland |
| Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej | Krakow | 31-115 | Poland |
| Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie | Poznan | 61-866 | Poland |
| Centrum Onkologii - Instytut M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej | Warsaw | 02-781 | Poland |
| IPO do Porto; Servico de Oncologia Medica | Porto | 4200-072 | Portugal |
| Centrul de Oncologie Sfantul Nectarie | Craiova | 200347 | Romania |
| Regional Institute of Oncology Iasi | Iași | 700483 | Romania |
| Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy | Moscow | 115478 | Russia |
| St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary | Saint Petersburg | 197022 | Russia |
| Institute for Onc/Rad Serbia | Belgrade | 11000 | Serbia |
| Wits Clinical Research | Johannesberg | 2013 | South Africa |
| University of Pretoria; Department of Medical Oncology | Pretoria | 0002 | South Africa |
| Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia | Santiago de Compostela | LA Coruña | 15706 | Spain |
| Hospital Duran i Reynals; Oncologia | Barcelona | 08907 | Spain |
| Centro Oncologico MD Anderson International Espana | Madrid | 28033 | Spain |
| Hospital Universitario La Paz; Servicio de Oncologia | Madrid | 28046 | Spain |
| Instituto Valenciano Oncologia; Oncologia Medica | Valencia | 46009 | Spain |
| Hospital Universitario la Fe; Servicio de Oncologia | Valencia | 46026 | Spain |
| Ankara Baskent University Medicine Faculty; Gynaecology | Ankara | 06500 | Turkey (Türkiye) |
| Istanbul Uni of Medicine Faculty; Oncology Dept | Istanbul | 34390 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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