Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels
NCT ID: NCT00083928
Last Updated: 2013-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2004-05-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Å6 subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Ångstrom Pharmaceuticals
INDUSTRY
Locations
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University of Alabama, Birmingham
Birmingham, Alabama, United States
Desert Oasis Cancer Center
Casa Grande, Arizona, United States
California Oncology of the Central Valley
Fresno, California, United States
USC Keck School of Medicine Women's and Childrens Hospital
Los Angeles, California, United States
University of California Irvine Medical Center
Orange, California, United States
UC Davis Health System
Sacramento, California, United States
Scripps Cancer Center
San Diego, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Medical College of Georgia Dept. of OB/GYN
Saint Agusta, Georgia, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Gynecologic Oncology
Hinsdale, Illinois, United States
St. Vincent Gyn-Onc
Indianapolis, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
University of Louisville JG Brown Cancer Center
Louisville, Kentucky, United States
Hematology & Oncology Specialists
New Orleans, Louisiana, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Gabrail Cancer Center
Canton, Ohio, United States
OSU College of Medicine
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Gynecologic-Oncology Research and Development, LLC
Greenville, South Carolina, United States
Chattanooga GYN Oncology
Chattanooga, Tennessee, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Carilion Gynecologic Oncology Associates
Roanoke, Virginia, United States
Countries
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Other Identifiers
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Å6-003
Identifier Type: -
Identifier Source: org_study_id
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