Clinical trial NCT00083928: Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Primary Peritoneal Carcinoma
Keywords: Asymptomatic
subcutaneous
CA125 Progression
Angstrom
Ångstrom
ovarian cancer
Lead sponsor: Ångstrom Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-06-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Casa Grande
country: United States
facility: Desert Oasis Cancer Center
state: Arizona
city: Fresno
country: United States
facility: California Oncology of the Central Valley
state: California
city: Los Angeles
country: United States
facility: USC Keck School of Medicine Women's and Childrens Hospital
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Health System
state: California
city: San Diego
country: United States
facility: Scripps Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: St. Agusta
country: United States
facility: Medical College of Georgia Dept. of OB/GYN
state: Georgia
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Hinsdale
country: United States
facility: Gynecologic Oncology
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Gyn-Onc
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Louisville
country: United States
facility: University of Louisville JG Brown Cancer Center
state: Kentucky
city: New Orleans
country: United States
facility: Hematology & Oncology Specialists
state: Louisiana
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Columbus
country: United States
facility: OSU College of Medicine
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma College of Medicine
state: Oklahoma
city: Greenville
country: United States
facility: Gynecologic-Oncology Research and Development, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga GYN Oncology
state: Tennessee
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Roanoke
country: United States
facility: Carilion Gynecologic Oncology Associates
state: Virginia
Study officials:
References: