Clinical Trials

Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a RisingCA125 Levels

This study is recruiting patients

Sponsored by
Ångstrom Pharmaceuticals, Inc.

Purpose

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 125levels.

Condition	Treatment or Intervention	Phase
Ovarian Cancer	Drug: Å6	2

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy/Safety Study

Official Title: "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” (Protocol Å6-003).

Eligibility:
Ages Eligible for Study: 18 years
Genders Eligible for Study: Female

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 2x ULN (upper limit of normal) and a documented doubling to 2x the institution’s ULN. This criterion will be satisfied by 2 consecutive CA125measurements, separated by at least 1 and not more than 12 weeks, the earliest of which must be obtained within 12 weeks prior to patient screening
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

Expected Total Enrollment: 48-60

Locations and Contact Information

ALABAMA - Birmingham
University of Alabama at Birmingham
Principal Investigator: Dr. Warner Huh 205-934-4986
Study Coordinator: Patty Bunch 205 975 7281

ARIZONA – Casa Grande
Desert Oasis Cancer Center
Study Coordinator: Charmaine Metrolis 520 876 5770

CALIFORNIA – Fresno
California Oncology of the Central Valley
Study Coordinator: Carolyn Gaston 559 438 7390

CALIFORNIA – Los Angeles
USC Keck School of Medicine
Study Coordinator: Grace Facio 323 226 7027

CALIFORNIA - Orange
University of California, Irvine Medical Center, Orange
Study Coordinator: Anita Wallock 714 456 8478

CALIFORNIA - Sacramento
UC Davis Health System
Study Coordinator: Cathy Hollister 916 734 8814

CALIFORNIA – San Diego
Scripps Cancer Center
Study Coordinator: Terry Bryntesen 858-554-8629

COLORADO – Aurora
University of Colorado Cancer Center
Study Coordinator: Amity Helzer 720 848 0666

FLORIDA - Orlando
Florida Hospital Cancer Institute, Orlando
Study Coordinator: Jane LeBlanc 407-303-2090

GEORGIA – Agusta
Medical College of Georgia, Dept. of OB/GYN
Study Coordinator: Nora McClendon 706 721 5557

HAWAII – Honolulu
Tripler Army Medical Center
Principal Investigator: Dr. John McBroom 808 433 6621

ILLINOIS - Hinsdale
Gynecologic Oncology
Principal Investigator: Dr. S.K. Sharma 630-856-6757
Clinical Coordinator: Peg Gregus 630-856-6757

INDIANA – Indianapolis
St. Vincent Gyn-Onc
Study Coordinator: Shirley Antock 317 415 6747

INDIANA – South Bend
Northern Indiana Cancer Research Consortium
Study Coordinator: Lisa Barnaby 574 237 7784

KENTUCKY – Louisville
University of Louisville
Study Coordinator: Shana Bowling 502 629 2851

LOUISIANA – New Orleans
Hematology & Oncology Specialists
Study Coordinator: Mary Ann Ostroske 504 894 7115 x 221

MISSOURI – St. Louis
Washington University School of Medicine
Study Coordinator: Lynne Lippman 314 362 1760

OHIO - Canton
Gabrail Cancer Center
Clinical Coordinator: Carry Smith 303 492 3345 x 208

OHIO - Columbus
Ohio State University College of Medicine
Principal Investigator: Dr. David Cohn 614-293-8737
Clinical Coordinator: Kristi Frenken 614-293-3873

OKLAHOMA – Oklahoma City
University of Oklahoma College of Medicine
Clinical Study Supervisor: Marsha Gayman 405-271-8001 x 48197

SOUTH CAROLINA – Greenville
Gynecologic-Oncology Research and Development, LLC
Study Coordinator: Jeanne Surprenant 864-271-7377

TENNESSEE - Chattanooga
Chattanooga GYN Oncology
Clinical Coordinator: Maria Bartley 423-698-2050

TEXAS - Houston
Brooke Army Medical Center, Fort Sam Houston
Principal Investigator: Dr. William Winter 210-916-3899

VIRGINIA - Roanoke
Cancer Outreach Associates
Clinical Coordinator: Darla Lovern 540 345 8574