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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
N/A
Not Enrolling
Female
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
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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

Å6-003

NCT ID:

NCT00083928

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

Name

Location

University of Colorado Cancer CenterDenver, Colorado  80262
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Florida Hospital Cancer InstituteOrlando, Florida  32804
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
Gynecologic OncologyHinsdale, Illinois  60521
Scripps Cancer CenterLa Jolla, California  92037
Gabrail Cancer CenterCanton, Ohio  44718
California Oncology of the Central ValleyFresno, California  93710
Chattanooga GYN OncologyChattanooga, Tennessee  37403
University of Alabama, BirminghamBirmingham, Alabama  35233
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Desert Oasis Cancer CenterCasa Grande, Arizona  85222
USC Keck School of Medicine Women's and Childrens HospitalLos Angeles, California  90033
University of California Irvine Medical CenterOrange, California  92668
UC Davis Health SystemSacramento, California  95817
Medical College of Georgia Dept. of OB/GYNSt. Agusta, Georgia  30912
St. Vincent Gyn-OncIndianapolis, Indiana  46260
University of Louisville JG Brown Cancer CenterLouisville, Kentucky  40202
Hematology & Oncology SpecialistsNew Orleans, Louisiana  70115
Barnes Jewish HospitalSt. Louis, Missouri  63110
OSU College of MedicineColumbus, Ohio  43210
Gynecologic-Oncology Research and Development, LLCGreenville, South Carolina  29601