search
Back to results

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

Primary Purpose

Ovarian Cancer, Primary Peritoneal Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Å6 subcutaneous injection
Sponsored by
Ångstrom Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Asymptomatic, subcutaneous, CA125 Progression, Angstrom, Ångstrom, ovarian cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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: 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. 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

Sites / Locations

  • University of Alabama, Birmingham
  • Desert Oasis Cancer Center
  • California Oncology of the Central Valley
  • USC Keck School of Medicine Women's and Childrens Hospital
  • University of California Irvine Medical Center
  • UC Davis Health System
  • Scripps Cancer Center
  • University of Colorado Cancer Center
  • Florida Hospital Cancer Institute
  • Medical College of Georgia Dept. of OB/GYN
  • Tripler Army Medical Center
  • Gynecologic Oncology
  • St. Vincent Gyn-Onc
  • Northern Indiana Cancer Research Consortium
  • University of Louisville JG Brown Cancer Center
  • Hematology & Oncology Specialists
  • Barnes Jewish Hospital
  • Gabrail Cancer Center
  • OSU College of Medicine
  • University of Oklahoma College of Medicine
  • Gynecologic-Oncology Research and Development, LLC
  • Chattanooga GYN Oncology
  • Brooke Army Medical Center
  • Carilion Gynecologic Oncology Associates

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 3, 2004
Last Updated
January 22, 2013
Sponsor
Ångstrom Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00083928
Brief Title
Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ångstrom Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Primary Peritoneal Carcinoma
Keywords
Asymptomatic, subcutaneous, CA125 Progression, Angstrom, Ångstrom, ovarian cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Å6 subcutaneous injection

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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. 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
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Desert Oasis Cancer Center
City
Casa Grande
State/Province
Arizona
ZIP/Postal Code
85222
Country
United States
Facility Name
California Oncology of the Central Valley
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
USC Keck School of Medicine Women's and Childrens Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92668
Country
United States
Facility Name
UC Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Scripps Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Medical College of Georgia Dept. of OB/GYN
City
St. Agusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Tripler Army Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96859
Country
United States
Facility Name
Gynecologic Oncology
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
St. Vincent Gyn-Onc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
University of Louisville JG Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Hematology & Oncology Specialists
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Barnes Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
OSU College of Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma College of Medicine
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Gynecologic-Oncology Research and Development, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Chattanooga GYN Oncology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Carilion Gynecologic Oncology Associates
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs