Trial | NCT00083928  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
Study Started
May 31
2004
Primary Completion
Feb 28
2006
Study Completion
Dec 31
2006
Last Update
Jan 24
2013
Estimate

Drug Å6 subcutaneous injection

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
No Results Posted