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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00083928

Enrollment

Registered

2004-06-07

Start date

2004-05-31

Completion date

2006-12-31

Last updated

2013-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer, Primary Peritoneal Carcinoma

Keywords

Asymptomatic, subcutaneous, CA125 Progression, Angstrom, Ångstrom, ovarian cancer

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.

Interventions

DRUGÅ6 subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026