Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well Hu3S193 works as a consolidation therapy for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.
Fallopian Tube Cancer
Peritoneal Cavity Cancer
Biological: Monoclonal antibody Hu3S193
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Hu3S193 Consolidation Therapy for Patients With Relapsing Platinum-sensitive Ovarian, Primary Peritoneal and Fallopian Tubes Adenocarcinoma, Who Achieved a Second Complete Response|
- Increase of Progression Free Survival [ Time Frame: From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first. An average of 16.5 months is expected. ] [ Designated as safety issue: No ]PFS is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period. Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.
- Two-year overall survival rate [ Time Frame: 2 years from the beginning of platinum-based rescue chemotherapy start date ] [ Designated as safety issue: No ]
- Safety [ Time Frame: From the first infusion date up to 30 days after patient's last infusion date ] [ Designated as safety issue: Yes ]Vital signs and adverse events will be assessed throughout the study treatment. Patients will be closely followed regarding adverse events for a period of up to 30 days after the last intravenous application of investigational product, until adverse events are resolved or until they begin a new treatment. After the 30-day period, the investigator may report the adverse events that in his/her opinion are related to the investigational product.
- 1-year disease progression-free survival rate [ Time Frame: 1 year from the beginning of platinum-based rescue chemotherapy start date ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Monoclonal antibody hu3S193
Monoclonal antibody hu3S193 will be administered to 51 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.
Biological: Monoclonal antibody Hu3S193
30 mg/m2 of Monoclonal antibody Hu3S193, IV as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). Anti-Lewis Y humanized monoclonal antibody designated "orphan drug" by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation.
This is a phase II multicenter trial with Hu3S193 as a single agent in a consolidation strategy in patients with relapsing platinum-sensitive ovarian, primary peritoneal and fallopian tubes cancer who achieve a second Complete Response after a platinum-based chemotherapy after platinum-based chemotherapeutical regimen. Fifty-one (51) patients with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tubes adenocarcinoma will receive doses of 30 mg/m2 of Hu3S193 as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). After the treatment period, patients will be evaluated every 3 months for the first two years, and every 6 months for more 3 years, and then in an annual-basis until disease progression or death, whichever happens first.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137071
|Núcleo de Oncologia da Bahia|
|Salvador, Bahia, Brazil, 40170-110|
|Cetus Hospital-Dia Oncologia Ltda - Filial Belo Horizonte|
|Belo Horizonte, Minas Gerais, Brazil, 30150-280|
|Hospital Erasto Gaertner|
|Curitiba, Paraná, Brazil, 81520-060|
|Hospital de Clínicas de Porto Alegre|
|Porto Alegre, Rio Grande do Sul, Brazil, 90035-903|
|Hospital de Câncer de Barretos|
|Barretos, São Paulo, Brazil, 14784-700|
|Fundação Amaral Carvalho|
|Jaú, São Paulo, Brazil, 17210-080|
|Hospital Israelita Albert Einstein|
|São Paulo, Brazil, 05651-901|
|Instituto do Câncer do Estado de São Paulo "Octávio Frias de Oliveira"|
|São Paulo, Brazil, 01246-000|
|Study Chair:||Oren Smaletz, MD||Recepta Biopharma S.A.|