Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels
Ovarian Cancer, Primary Peritoneal Carcinoma
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Asymptomatic, subcutaneous, CA125 Progression, Angstrom, Ångstrom, ovarian cancer
Eligibility Criteria
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
Sites / Locations
- University of Alabama, Birmingham
- Desert Oasis Cancer Center
- California Oncology of the Central Valley
- USC Keck School of Medicine Women's and Childrens Hospital
- University of California Irvine Medical Center
- UC Davis Health System
- Scripps Cancer Center
- University of Colorado Cancer Center
- Florida Hospital Cancer Institute
- Medical College of Georgia Dept. of OB/GYN
- Tripler Army Medical Center
- Gynecologic Oncology
- St. Vincent Gyn-Onc
- Northern Indiana Cancer Research Consortium
- University of Louisville JG Brown Cancer Center
- Hematology & Oncology Specialists
- Barnes Jewish Hospital
- Gabrail Cancer Center
- OSU College of Medicine
- University of Oklahoma College of Medicine
- Gynecologic-Oncology Research and Development, LLC
- Chattanooga GYN Oncology
- Brooke Army Medical Center
- Carilion Gynecologic Oncology Associates