Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

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

Criterios de exclusión

Prior radiotherapy delivered using cobalt
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 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

Intervenciones

drug

Bevacizumab

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

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

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Bevacizumab

Carboplatin

Paclitaxel

Ubicaciones

Centro Oncologico Riojano Integral (CORI)

Patrocinadores