Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels

Completed · Phase 2

Conditions studied: Ovarian Cancer, Primary Peritoneal Carcinoma

In brief

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.

Key facts

Study ID

NCT00083928

Run by

Ångstrom Pharmaceuticals

People needed

60

Starts

2004-05-01

Expected to finish

2006-12-01

Last updated by the study team

2013-01-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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