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The purpose of this study is to determine whether injections of Ã…6 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ã…6 subcutaneous injection | Drug |
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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Desert Oasis Cancer Center |
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| 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 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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