Hu3S193 in Treating Women With Ovarian Epithelial, 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 in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.
Fallopian Tube Cancer
Primary Peritoneal Cancer
|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 THERAPY FOR PATIENTS WITH PLATINUM REFRACTORY OR PLATINUM RESISTANT EPITHELIAL OVARIAN, PRIMARY PERITONEAL AND FALLOPIAN TUBE CANCER|
- RECIST criteria or CA-125 level [ Time Frame: baseline and every 8 weeks up to 24 weeks ] [ Designated as safety issue: No ]
- Occurence of adverse events, safety laboratory variables and vital signs [ Time Frame: From the inclusion up to 30 days after the last dose of investigational agent ] [ Designated as safety issue: Yes ]
- C max over time [ Time Frame: 10 minutes before and 1 hour after the infusion (first 8 weeks) ] [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
- To evaluate the efficacy of monoclonal antibody Hu3S193 in women with platinum-resistant/refractory ovarian, fallopian tube, or primary peritoneal cancer, based on RECIST criteria.
- To determine the safety of the study drug.
- To determine the drug pharmacokinetics when administered in multiple weekly injections.
OUTLINE: This is a multicenter study.
Patients receive monoclonal antibody Hu3S193 IV over 1 hour once weekly in weeks 1-8. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed monthly.
|Hospital de Clinicas de Porto Alegre|
|Porto Alegre, Rio Grande do Sul, Brazil, 90035-903|
|Hospital da Baleia|
|Minas Gerais, Brazil, 30285-000|
|Hospital Sao Lucas da PUCRS|
|Porto Alegre, Brazil, 90610-000|
|Instituto Nacional de Cancer|
|Rio de Janeiro, Brazil, 20220-410|
|Sao Paulo, Brazil, 01308-050|
|Hospital Israelita Albert Einstein|
|Sao Paulo, Brazil, 05651-901|
|Hospital das Clinicas FMUSP|
|Sao Paulo, Brazil, 01246-000|
|Hospital Alemao Oswaldo Cruz|
|Sao Paulo, Brazil, 01401-904|
|Study Chair:||Oren Smaletz, MD||Recepta Biopharma|