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

January 22, 2013 updated by: Ångstrom Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama, Birmingham
    • Arizona
      • Casa Grande, Arizona, United States, 85222
        • Desert Oasis Cancer Center
    • California
      • Fresno, California, United States, 93710
        • California Oncology of the Central Valley
      • Los Angeles, California, United States, 90033
        • USC Keck School of Medicine Women's and Childrens Hospital
      • Orange, California, United States, 92668
        • University of California Irvine Medical Center
      • Sacramento, California, United States, 95817
        • UC Davis Health System
      • San Diego, California, United States, 92121
        • Scripps Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80010
        • University of Colorado Cancer Center
    • Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
    • Georgia
      • St. Agusta, Georgia, United States, 30912
        • Medical College of Georgia Dept. of OB/GYN
    • Hawaii
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Gynecologic Oncology
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Gyn-Onc
      • South Bend, Indiana, United States, 46617
        • Northern Indiana Cancer Research Consortium
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville JG Brown Cancer Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Hematology & Oncology Specialists
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Columbus, Ohio, United States, 43210
        • OSU College of Medicine
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73190
        • University of Oklahoma College of Medicine
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Gynecologic-Oncology Research and Development, LLC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Chattanooga GYN Oncology
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Gynecologic Oncology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ångstrom Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

June 3, 2004

First Submitted That Met QC Criteria

June 4, 2004

First Posted (Estimate)

June 7, 2004

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Å6-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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