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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ovarian Cancer, Primary Peritoneal Carcinoma

Intervention / Treatment
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* Drug: Å6 subcutaneous injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Å6 subcutaneous injection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asymptomatic, subcutaneous, CA125 Progression, Angstrom, Ångstrom, ovarian cancer