Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels

Inclusion criteria

• Females ≥18 years of age
• Histologically or cytologically documented primary epithelial ovarian carcinoma, cancer of the Fallopian tube, or primary peritoneal carcinoma
• Completion of first-line chemotherapy
• Clinical remission as a result of chemotherapy
• History of normal CA125 level after initial course of therapy
• CA125 serum level has shown 2 consecutive rises based on 3 consecutive samples which are mutually >= 28 days apart, provided that:

• the 3rd sample is above the institution's ULN, and
• the 3rd sample is confirmed by a 4th sample which is likewise higher than the 2nd sample value and is above the institution's ULN
• No clinically evident disease progression, as assessed by history, physical examination, computed tomographic (CT) scan, or magnetic resonance imaging (MRI)
• ECOG Performance Status of 0 or 1
• No clinically significantly abnormal clinical laboratory tests or concomitant illnesses
• Ability and willingness to self-administer subcutaneous injections
• Although pregnancy is extremely unlikely in this patient population because of the disease and prior treatment, patients who have the potential to become pregnant must have a negative pregnancy test and must agree to practice an effective method of contraception throughout the trial.

Exclusion criteria

• Persistent adverse events due to agents administered more than 4 weeks earlier
• More than 1 course of previous chemotherapy for the qualifying cancer
• Disease requiring chemotherapy or radiotherapy
• Ascites
• Recent history of active infection, gastrointestinal bleeding, thromboembolic disorders, or anticoagulation