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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

June 3, 2004
January 22, 2013
May 2004
February 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00083928 on ClinicalTrials.gov Archive Site
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Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Ovarian Cancer
  • Primary Peritoneal Carcinoma
Drug: Å6 subcutaneous injection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2006
February 2006   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00083928
Å6-003
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Ångstrom Pharmaceuticals
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Not Provided
Ångstrom Pharmaceuticals
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP