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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

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Primary Peritoneal Carcinoma

Thank you

Trial Information

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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

May 2004

Completion Date:

December 2006

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • Asymptomatic
  • subcutaneous
  • CA125 Progression
  • Angstrom
  • Ångstrom
  • ovarian cancer
  • Carcinoma
  • Ovarian Neoplasms



University of Colorado Cancer Center Denver, Colorado  80262
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Florida Hospital Cancer Institute Orlando, Florida  32804
Carilion Gynecologic Oncology Associates Roanoke, Virginia  24014
Gynecologic Oncology Hinsdale, Illinois  60521
Scripps Cancer Center La Jolla, California  92037
Gabrail Cancer Center Canton, Ohio  44718
California Oncology of the Central Valley Fresno, California  93710
Chattanooga GYN Oncology Chattanooga, Tennessee  37403
University of Alabama, Birmingham Birmingham, Alabama  35233
Northern Indiana Cancer Research Consortium South Bend, Indiana  
Desert Oasis Cancer Center Casa Grande, Arizona  85222
USC Keck School of Medicine Women's and Childrens Hospital Los Angeles, California  90033
University of California Irvine Medical Center Orange, California  92668
UC Davis Health System Sacramento, California  95817
Medical College of Georgia Dept. of OB/GYN St. Agusta, Georgia  30912
St. Vincent Gyn-Onc Indianapolis, Indiana  46260
University of Louisville JG Brown Cancer Center Louisville, Kentucky  40202
Hematology & Oncology Specialists New Orleans, Louisiana  70115
Barnes Jewish Hospital St. Louis, Missouri  63110
OSU College of Medicine Columbus, Ohio  43210
Gynecologic-Oncology Research and Development, LLC Greenville, South Carolina  29601