Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma
Conditions
Ovarian Neoplasms - Ovarian Epithelial Cancer
Conditions: official terms
Neoplasms, Glandular and Epithelial - Ovarian Neoplasms
Conditions: Keywords
serous, endometrioid, mucinous, epithelial ovarian cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: DCVAC/OvCa with Standard of Care Type: Biological
Name: DCVAC/OvCa sequentially chemotherapy Type: Biological
Name: Standard of Care Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of progression free survival (PFS).
Detailed Description
The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of progression free survival (PFS).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Female aged ≥18 years

- Patients with newly diagnosed, histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous) who have undergone initial surgery up to 3 weeks before randomization and are selected to receive first line Standard of Care chemotherapy (optional prolongation to 6 weeks after surgery)

- Optimally debulked (zero residuum) or maximal residuum <1cm

- Eastern Cooperative Oncology Group (ECOG) Performance status 0,1,2

Exclusion Criteria:

- FIGO I,II,IV epithelial ovarian cancer

- FIGO III clear cells epithelial ovarian cancer

- Non-epithelial ovarian cancer (OvCa), borderline tumors (tumors of low malignant potential)

- Post-surgery residual disease with lesion(s) >1cm

- Prior or current systemic anti-cancer therapy for ovarian cancer [for example chemotherapy, monoclonal antibody therapy (bevacizumab), tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy]

- Previous or concurrent radiotherapy to the abdomen and pelvis

- Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas

- Patient co-morbidities:Human immunodeficiency virus (HIV) positive, human T-lymphotropic virus (HTLV) positive, Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis

- Evidence of active bacterial, viral or fungal infection requiring systemic treatment

- Clinically significant cardiovascular disease including:

Symptomatic congestive heart failure Unstable angina pectoris Serious cardiac arrhythmia requiring medication Uncontrolled hypertension Myocardial infarction or ventricular arrhythmia or stroke within a 6 month period before inclusion, ejection fraction (EF) < 40 percent or serious cardiac conduction system disorders, if a pacemaker is not present
Locations
Brno, Czech Republic
Status: Recruiting
Brno, Czech Republic
Status: Recruiting
Hradec Králové, Czech Republic
Status: Recruiting
Jihlava, Czech Republic
Status: Recruiting
Nový Jičín, Czech Republic
Status: Recruiting
Olomouc, Czech Republic
Status: Recruiting
Ostrava, Czech Republic
Status: Recruiting
Plzeň, Czech Republic
Status: Recruiting
Praha 5, Czech Republic
Status: Recruiting
Praha, Czech Republic
Status: Recruiting
Ústí nad Labem, Czech Republic
Status: Recruiting
České Budějovice, Czech Republic
Status: Recruiting
Dresden, Germany
Status: Recruiting
Erlangen, Germany
Status: Recruiting
Köln, Germany
Status: Recruiting
Bialystok, Poland
Status: Recruiting
Krakow, Poland
Status: Recruiting
Lublin, Poland
Status: Recruiting
Poznan, Poland
Status: Recruiting
Start Date
November 2013
Completion Date
September 2017
Sponsors
Sotio a.s.
Source
Sotio a.s.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page