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Spots Global Cancer Trial Database for Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

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Trial Identification

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

Interventions

hu3S193

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Oren Smaletz, MD

Affiliation: Recepta Biopharma

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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