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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00083928
• Other study ID #: Å6-003
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2004
• Last updated: January 22, 2013
• Start date: May 2004
• Est. completion date: December 2006

Study information

• Verified date: January 2013
• Source: Ångstrom Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

Intervention

Drug:
• Å6 subcutaneous injection

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Gabrail Cancer Center	Canton	Ohio
United States	Desert Oasis Cancer Center	Casa Grande	Arizona
United States	Chattanooga GYN Oncology	Chattanooga	Tennessee
United States	OSU College of Medicine	Columbus	Ohio
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	California Oncology of the Central Valley	Fresno	California
United States	Gynecologic-Oncology Research and Development, LLC	Greenville	South Carolina
United States	Gynecologic Oncology	Hinsdale	Illinois
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	St. Vincent Gyn-Onc	Indianapolis	Indiana
United States	USC Keck School of Medicine Women's and Childrens Hospital	Los Angeles	California
United States	University of Louisville JG Brown Cancer Center	Louisville	Kentucky
United States	Hematology & Oncology Specialists	New Orleans	Louisiana
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	University of California Irvine Medical Center	Orange	California
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	Carilion Gynecologic Oncology Associates	Roanoke	Virginia
United States	UC Davis Health System	Sacramento	California
United States	Scripps Cancer Center	San Diego	California
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	Barnes Jewish Hospital	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Ångstrom Pharmaceuticals

Country where clinical trial is conducted

United States,