Status:
COMPLETED
Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels
Lead Sponsor:
Ångstrom Pharmaceuticals
Conditions:
Ovarian Cancer
Primary Peritoneal Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00083928
Start Date
May 1 2004
End Date
December 1 2006
Last Update
January 24 2013
Active Locations (24)
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1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35233
2
Desert Oasis Cancer Center
Casa Grande, Arizona, United States, 85222
3
California Oncology of the Central Valley
Fresno, California, United States, 93710
4
USC Keck School of Medicine Women's and Childrens Hospital
Los Angeles, California, United States, 90033