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

This study has been completed.
Sponsor:
Information provided by:
Ångstrom Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00083928
First received: June 3, 2004
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Carcinoma
Drug: Å6 subcutaneous injection
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Ångstrom Pharmaceuticals:

Estimated Enrollment: 60
Study Start Date: May 2004
Study Completion Date: December 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083928

  Show 24 Study Locations
Sponsors and Collaborators
Ångstrom Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00083928     History of Changes
Other Study ID Numbers: Å6-003
Study First Received: June 3, 2004
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ångstrom Pharmaceuticals:
Asymptomatic
subcutaneous
CA125 Progression
Angstrom
Ångstrom
ovarian cancer

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on August 27, 2014