A Phase 2 Randomized, Double-Blind Trial of the Clinical Activity and Safety of Å6 in Patients With Asymptomatic CA125 Progression of Epithelial Ovarian Cancer After First-Line Chemotherapy

Date de début de l'étude : 1 mai 2004

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: 1. the 3rd sample is above the institution's ULN, and 2. 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