NCT00617773

Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

A PHASE II TRIAL OF Hu3S193 THERAPY FOR PATIENTS WITH PLATINUM REFRACTORY OR PLATINUM RESISTANT EPITHELIAL OVARIAN, PRIMARY PERITONEAL AND FALLOPIAN TUBE CANCER

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Recepta Biopharma · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	hu3S193	20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)

Timeline

• Start date: 2008-05-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2008-02-18
• Last updated: 2013-11-26
• Results posted: 2013-11-26

Locations

8 sites across 1 country: Brazil