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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 3, 2004
Last Updated Date	January 22, 2013
Start Date ^ICMJE	May 2004
Primary Completion Date	February 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00083928 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Ovarian Cancer Primary Peritoneal Carcinoma
Intervention ^ICMJE	Drug: Å6 subcutaneous injection
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	60
Completion Date	December 2006
Primary Completion Date	February 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00083928
Other Study ID Numbers ^ICMJE	Å6-003
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Ångstrom Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Ångstrom Pharmaceuticals
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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