Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels
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
1 other identifier
interventional
60
1 country
24
Brief Summary
The purpose of this study is to determine whether injections of Å6 are effective in treating ovarian cancer patients who have completed first-line therapy and currently have no detectable cancer but have experienced a doubling of CA 125 levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 ovarian-cancer
Started May 2004
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 3, 2004
CompletedFirst Posted
Study publicly available on registry
June 7, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJanuary 24, 2013
January 1, 2013
1.8 years
June 3, 2004
January 22, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
University of Alabama, Birmingham
Birmingham, Alabama, 35233, United States
Desert Oasis Cancer Center
Casa Grande, Arizona, 85222, United States
California Oncology of the Central Valley
Fresno, California, 93710, United States
USC Keck School of Medicine Women's and Childrens Hospital
Los Angeles, California, 90033, United States
University of California Irvine Medical Center
Orange, California, 92668, United States
UC Davis Health System
Sacramento, California, 95817, United States
Scripps Cancer Center
San Diego, California, 92121, United States
University of Colorado Cancer Center
Aurora, Colorado, 80010, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Medical College of Georgia Dept. of OB/GYN
Saint Agusta, Georgia, 30912, United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859, United States
Gynecologic Oncology
Hinsdale, Illinois, 60521, United States
St. Vincent Gyn-Onc
Indianapolis, Indiana, 46260, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46617, United States
University of Louisville JG Brown Cancer Center
Louisville, Kentucky, 40202, United States
Hematology & Oncology Specialists
New Orleans, Louisiana, 70115, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
OSU College of Medicine
Columbus, Ohio, 43210, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190, United States
Gynecologic-Oncology Research and Development, LLC
Greenville, South Carolina, 29601, United States
Chattanooga GYN Oncology
Chattanooga, Tennessee, 37403, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Carilion Gynecologic Oncology Associates
Roanoke, Virginia, 24014, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 3, 2004
First Posted
June 7, 2004
Study Start
May 1, 2004
Primary Completion
February 1, 2006
Study Completion
December 1, 2006
Last Updated
January 24, 2013
Record last verified: 2013-01