Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer
Conditions
Recurrent Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
second line, platinum sensitive, first line bevacizumab, biologic factors, clinical factors
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Bevacizumab Type: Drug
Name: Paclitaxel Type: Drug
Name: Carboplatin Type: Drug
Name: pegylated liposomal doxorubicin Type: Drug
Name: Gemcitabine Type: Drug
Overall Status
Recruiting
Summary
Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab.

Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined.

This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Female patients ≥18 years of age.

- Patients with histologically confirmed epithelial ovarian or fallopian tube carcinoma or primary peritoneal carcinoma, including mixed Mullerian Tumours

- Recurrence or progression at least 6 months after the last chemotherapy cycle of a first line carboplatin + paclitaxel chemotherapy including bevacizumab (recurrence or progression might occur either during or after bevacizumab as maintenance)

- Patients can be included if they have a RECIST progression, with either measurable or non-measurable disease

- ECOG (Eastern Cooperative Oncology Group Performance) Status of 0-2.

- Life expectancy of at least 12 weeks.

- Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements including blood samples for molecular analyses.

- Availability of tumour samples for molecular analyses from primary surgery (mandatory) and secondary surgery (when available)

Exclusion Criteria:

Cancer related

- Ovarian tumours with low malignant potential (i.e. borderline tumours)

- History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met:

- stage ≤Ia

- no more than superficial myometrial invasion

- no lymphovascular invasion

- not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma).

- Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.

Prior current or planned treatment:

- More than one previous chemotherapy line

- Previous therapy with other anti-angiogenetic agents different from bevacizumab.

- Any prior radiotherapy to the pelvis or abdomen.

- Surgery (including open biopsy) within 4 weeks prior to the first bevacizumab dose.Current or recent (within 10 days prior to the first study drug dose) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes (except for line patency, in which case international normalized ratio [INR] must be maintained below 1.5). Post operative prophylaxis with low molecular weight heparin sc is allowed.

- Current or recent (within 30 days of first study dosing) treatment with any other investigational drug.

Laboratory:

- Inadequate bone marrow function: ANC (absolute neutrophil count): <1500/mm3, or platelet count <100,000/mm3 or Haemoglobin <9 g/dl. Patients may be transfused to maintain haemoglobin values ≥9 g/dl.

- Inadequate coagulation parameters:

- activated partial thromboplastin time (APTT) >1.5 x upper limit of normal (ULN) or

- INR (international normalized ratio) >1.5

- Inadequate liver function, defined as:

- serum (total) bilirubin >1.5 x ULN for the institution

- AST/SGOT or ALT/SGPT > 2.5 x ULN.

- Inadequate renal function, defined as:

- serum creatinine >2.0 mg/dl or >177 micromol/l

- urine dipstick for proteinuria >2+. Patients with ≥ 1+ proteinuria at baseline dipstick analysis should undergo a 24-hour urine collection and must demonstrate ≤1g of protein in their 24-hour urine collection.

Prior or concomitant conditions or procedures:

- History or evidence of brain metastases or spinal cord compression.

- Pregnant or lactating females.

- History or evidence of thrombotic or haemorrhagic disorders; including cerebrovascular accident (CVA) / stroke or transient ischemic attack (TIA) or sub-arachnoid haemorrhage within ≤6 months prior to the first study treatment).

- Uncontrolled hypertension (sustained systolic >150 mm Hg and/or diastolic >100 mm Hg despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease, including:

- myocardial infarction or unstable angina within ≤6 months prior to the first study treatment

- New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF)

- serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia)

- peripheral vascular disease ≥grade 3 (i.e. symptomatic and interfering with activities of daily living requiring repair or revision).

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess, or with signs of impending bowel obstruction within 6 months prior to the first study treatment.

- Non-healing wound, ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require three weekly wound examinations.

- Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
Locations
Centre Hospitalier d'Aix-en-Provence
Aix-en-Provence, France
Status: Recruiting
Hôpital de la Côte Basque
Bayonne, France
Status: Recruiting
Institut Bergoniè
Bordeaux, France
Status: Recruiting
Centre François Baclesse
Caen, France
Status: Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, France
Status: Recruiting
Centre d'Oncologie et de Radiothérapie
Dijon, France
Status: Recruiting
Centre Georges Francois Leclerc
Dijon, France
Status: Recruiting
Centre Hospitalier du Mans
Le Mans, France
Status: Recruiting
Centre Hospitalier Universitaire Dupuytren
Limoges, France
Status: Recruiting
Centre Léon Bérard
Lyon, France
Status: Recruiting
Clinique de la Sauvegarde
Lyon, France
Status: Recruiting
Hôpital Nord
Marseille, France
Status: Recruiting
Hôpital Saint-Joseph
Marseille, France
Status: Recruiting
Clinique Claude Bernard
Metz, France
Status: Recruiting
Centre Azuréen de Cancérologie
Mougins, France
Status: Recruiting
Centre Hospitalier Général de Pau
Paris, France
Status: Recruiting
Hopital Cochin
Paris, France
Status: Recruiting
Hôpital des Diaconesses
Paris, France
Status: Recruiting
Hôpital Tenon
Paris, France
Status: Recruiting
Centre Hospitalier de la Région d'Annecy
Pringy, France
Status: Recruiting
Institut Jean Godinot
Reims, France
Status: Recruiting
Hopital Renè Huguenin, Institut Curie
Saint Cloud, France
Status: Recruiting
Hôpital Inter Armées de Begin (HIA Begin),
Saint Mande, France
Status: Recruiting
GHPSO
Senlis, France
Status: Recruiting
Centre de Radiothèrapie - Clinique Sainte-Anne
Strausbourg, France
Status: Recruiting
Clinique des Dentellières,
Valenciennes, France
Status: Recruiting
Institut de Cancérologie Gustave Roussy
Villejuif, France
Status: Recruiting
Centro di Riferimento Oncologico
Aviano, Italy
Status: Recruiting
A.O. G. Rummo
Benevento, Italy
Status: Recruiting
Ospedale Senatore Antonio Perrino
Brindisi, Italy
Status: Recruiting
Fondazione del Piemonte per l'Oncologia IRCCS
Candiolo, Italy
Status: Recruiting
Ospedale Civile di Faenza
Faenza, Italy
Status: Recruiting
I.R.C.C.S. San Martino IST
Genova, Italy
Status: Recruiting
Ospedale Galliera
Genova, Italy
Status: Recruiting
ASL 5 Spezzino Ospedale Felettino
La Spezia, Italy
Status: Recruiting
A.O. Vito Fazzi
Lecce, Italy
Status: Recruiting
Ospedale Manzoni di Lecco
Lecco, Italy
Status: Recruiting
Istituto Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
Status: Recruiting
Istituto Europeo di Oncologia
Milano, Italy
Status: Recruiting
Istituto Nazionale Tumori
Milano, Italy
Status: Recruiting
U.L.S.S. 13
Mirano, Italy
Status: Recruiting
A.O.U. Federico II
Napoli, Italy
Status: Recruiting
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Napoli, Italy
Status: Recruiting
NO AOU Maggiore della Carità
Novara, Italy
Status: Recruiting
Casa di Cura La Maddalena
Palermo, Italy
Status: Recruiting
Osp Silvestrini
Perugia, Italy
Status: Recruiting
Ospedale S. Maria delle Croci AUSL di Ravenna
Ravenna, Italy
Status: Recruiting
Arcispedale S. Maria Nuova
Reggia Emilia, Italy
Status: Recruiting
Ospedale Civile Rimini
Rimini, Italy
Status: Recruiting
Ospedale S. Giovanni Calibita Fatebenefratelli
Roma, Italy
Status: Recruiting
Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore
Roma, Italy
Status: Recruiting
Policlinico Università Campus Biomedico
Roma, Italy
Status: Recruiting
A.O. di Udine S. Maria della Misericordia
Udine, Italy
Status: Recruiting
Zentrum fùr Onkologie/ Hamat. und Transf
Aarau, Switzerland
Status: Recruiting
Universitatsspital,Frauenklinik
Basel, Switzerland
Status: Recruiting
IOSI
Bellinzona, Switzerland
Status: Recruiting
Klinik Engeried
Bern, Switzerland
Status: Recruiting
Kantonsspital
Chur, Switzerland
Status: Recruiting
Kantonsspital
Frauenfeld, Switzerland
Status: Recruiting
HUG Breast Center
Geneva, Switzerland
Status: Recruiting
Kantonsspital
Luzern, Switzerland
Status: Recruiting
Kantonsspital
Munsterlingen, Switzerland
Status: Recruiting
Kantonsspital
Olten, Switzerland
Status: Recruiting
Klinische Forschung Onkologie
St. Gallen, Switzerland
Status: Recruiting
Kantonsspital
Winterthur, Switzerland
Status: Recruiting
Start Date
November 2013
Completion Date
July 2016
Sponsors
National Cancer Institute, Naples
Source
National Cancer Institute, Naples
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page