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Brief Title: Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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
Study ID: NCT00617773
Brief Summary: 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.
Detailed Description: OBJECTIVES: Primary * 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 (Response Evaluation Criteria in Solid Tumors). Secondary * To determine the safety of the study drug. * To determine the drug pharmacokinetics when administered in multiple weekly injections. Exploratory analysis * Clinical Benefit (objective response rate + tumor stabilization). * Progression Free Survival (PFS). * Duration of Response. * Overall Survival. * 12-month survival rate. 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil
Hospital da Baleia, Minas Gerais, , Brazil
Hospital Sao Lucas da PUCRS, Porto Alegre, , Brazil
Instituto Nacional de Cancer, Rio de Janeiro, , Brazil
Hospital das Clinicas FMUSP, Sao Paulo, , Brazil
Hospital Sirio-Libanes, Sao Paulo, , Brazil
Hospital Alemao Oswaldo Cruz, Sao Paulo, , Brazil
Hospital Israelita Albert Einstein, Sao Paulo, , Brazil
Name: Oren Smaletz, MD
Affiliation: Recepta Biopharma
Role: STUDY_CHAIR