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

Phase 2

Completed

• Conditions: Ovarian Cancer; Primary Peritoneal Carcinoma

• Registration Number: NCT00083928
• Lead Sponsor: Ångstrom Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2004-06-03
• Study First Submitted QC: 2004-06-04
• Study First Posted: 2004-06-07
• Primary Completion: 2006-02
• Study Completion: 2006-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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:

  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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (24)

Barnes Jewish Hospital; 🇺🇸 St. Louis, Missouri, United States

Chattanooga GYN Oncology; 🇺🇸 Chattanooga, Tennessee, United States

University of Oklahoma College of Medicine; 🇺🇸 Oklahoma City, Oklahoma, 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

California Oncology of the Central Valley; 🇺🇸 Fresno, California, United States

Desert Oasis Cancer Center; 🇺🇸 Casa Grande, Arizona, United States

Scripps Cancer Center; 🇺🇸 San Diego, California, United States

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

Northern Indiana Cancer Research Consortium; 🇺🇸 South Bend, Indiana, United States

Medical College of Georgia Dept. of OB/GYN; 🇺🇸 St. Agusta, Georgia, United States

UC Davis Health System; 🇺🇸 Sacramento, California, United States

St. Vincent Gyn-Onc; 🇺🇸 Indianapolis, Indiana, United States

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States

Florida Hospital Cancer Institute; 🇺🇸 Orlando, Florida, United States

Tripler Army Medical Center; 🇺🇸 Honolulu, Hawaii, United States

Gabrail Cancer Center; 🇺🇸 Canton, Ohio, United States

University of Alabama, Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Louisville JG Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States

Gynecologic Oncology; 🇺🇸 Hinsdale, Illinois, United States

Hematology & Oncology Specialists; 🇺🇸 New Orleans, Louisiana, United States

Carilion Gynecologic Oncology Associates; 🇺🇸 Roanoke, Virginia, United States

OSU College of Medicine; 🇺🇸 Columbus, Ohio, United States

Gynecologic-Oncology Research and Development, LLC; 🇺🇸 Greenville, South Carolina, United States