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Ovarian Cancer Treatment Study

Clinical Trial Title: 
A study to assess the effectiveness and safety of farletuzumab in combination with carboplatin plus paclitaxel or carboplatin plus pegylated liposomal doxorubicin (PLD) in subjects with low CA125 platinum-sensitive ovarian cancer.
Clinical Trial Protocol ID: 
14100601
Clinical Trial Investigator Name: 
Summer B. Dewdney, MD
Clinical Trial Protocol Description: 

Cancer of the ovary is not common, but it causes more deaths than other female reproductive cancers. Ovarian cancer is hard to detect early. Women with ovarian cancer may have no symptoms or just mild symptoms until the disease is in an advanced stage.

The standard fist-line therapy for advanced ovarian cancer, following surgery, is platinum-based chemotherapy. Most ovarian cancers respond to initial treatment, although most will eventually relapse. The recurrence rate in patients with a clinical complete response after initial chemotherapy is 60-70%. The purpose of this study is to find out if carboplatin plus paclitaxel or carboplatin plus pegylated liposomal doxorubicin (PLD), chemotherapies which are used to treat ovarian cancer, work better alone or when given with an investigational drug called farletuzumab. 

Farletuzumab is a humanized monoclonal antibody that binds to the folate receptor alpha (FRA). Farletuzumab specifically targets at glycoprotein 3 (GP-3), a cell surface antigen that is overexpressed on many epithelial-derived cancer cells.

Subjects in this study will receive 6 cycles of standard chemotherapy and then be randomized to receive farletuzumab or placebo. This study is double-blinded, meaning neither you nor the study staff will know which study drug you are receiving. After 6 cycles of combined chemotherapy, subjects will receive farletuzumab or placebo without chemotherapy until their disease gets worse, they experience intolerable side effects, the subject decides to discontinue treatment, or the study is stopped.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have confirmed diagnosis of epithelial ovarian cancer with low CA125.
  • Have already had debulking surgery and received a first-line platinum-based chemotherapy treatment.
  • Have adequate organ and liver function.

You will be excluded from the study if any of the following criteria apply to you:

  • Have central nervous system tumor involvement.
  • Have clinically significant heart disease.
  • Have a known allergic reaction to a prior monoclonal antibody treatment.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Gynecologic Cancers
Contact Phone: 
(312) 942-2417 or (312) 942-7254
Contact Name: 
Lois Winkelman or Judith Dybinski