Back to resultsMonoclonal Antibody Therapy in Treating Patients With Residual Disease From Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Following Surgery and Chemotherapy
Primary Purpose
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
oregovomab
Sponsored by
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven stage III or IV ovarian epithelial, tubal, or peritoneal adenocarcinoma Must have had complete clinical response to primary therapy consisting of surgical debulking and platinum based chemotherapy Elevated CA 125 (greater than 35 U/mL) prior to or at surgery (if presurgical CA 125 measurement is not available, patient must have a serum CA 125 of at least 100 U/mL and strong tumor tissue expression) Must have residual disease (visible or palpable) at completion of the staging laparotomy (IIIB and IIIC microscopic disease) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 60-100% Life expectancy: At least 6 months Hematopoietic: Hemoglobin at least 8.0 g/dL Lymphocyte count at least 300/mm3 Neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.6 mg/dL PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy No prior murine monoclonal antibodies for diagnostic or therapeutic purposes Chemotherapy: No more than 1 prior regimen of chemotherapy (change in chemotherapy agents is permitted during primary therapy provided that the change is considered to be part of initial chemotherapy regimen) At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior abdominal, abdominopelvic, or pelvic radiotherapy Surgery: At least 4 weeks since prior surgery No more than 1 interval debulking procedure
Sites / Locations
- Alta Bates Comprehensive Cancer Center
- USC/Norris Comprehensive Cancer Center
- Jonsson Comprehensive Cancer Center, UCLA
- Chao Family Comprehensive Cancer Center
- Wilshire Oncology Medical Center
- Stanford University School of Medicine
- University of Colorado Cancer Center
- Patty Berg Cancer Center
- University of Florida Health Science Center - Jacksonville
- Walt Disney Memorial Cancer Institute
- University of Chicago Cancer Research Center
- Saint Mary's Hospital
- Lutheran General Cancer Care Center
- University of Iowa Hospitals and Clinics
- Alton Ochsner Medical Foundation Hospital
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
- New England Medical Center Hospital
- Henry Ford Hospital
- University of Minnesota Medical School
- Ellis Fischel Cancer Center
- North Shore University Hospital
- State University of New York - Upstate Medical University
- University of Oklahoma
- Spartanburg Regional Medical Center
- Baptist Regional Cancer Center - Knoxville
- University of Texas Southwestern Medical School
- U.S. Oncology
- Cancer Center, University of Virginia HSC
- Swedish Hospital Tumor Institute
- Tom Baker Cancer Center - Calgary
- Cross Cancer Institute
- British Columbia Cancer Agency - Fraser Valley Cancer Centre
- British Columbia Cancer Agency
- Manitoba Cancer Treatment and Research Foundation
- Saint John Regional Hospital
- Nova Scotia Cancer Centre
- Cancer Care Ontario-Hamilton Regional Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Credit Valley Hospital
- Ottawa Regional Cancer Center - General Division
- Northeastern Ontario Regional Cancer Centre, Sudbury
- Toronto Sunnybrook Regional Cancer Centre
- Centre Universitaire de Sante de l'Estrie
- Centre Hospitalier de l'Universite de Montreal
- Jewish General Hospital - Montreal
- Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00003634
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Residual Disease From Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Following Surgery and Chemotherapy
Official Title
A Double-Blind Placebo Controlled Trial of Intravenous OvaRex MAb-B43.13 as Post Chemotherapy Consolidation for Ovarian Tubal and Peritoneal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AltaRex
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether giving monoclonal antibody therapy is more effective than a placebo in treating patients with ovarian epithelial, fallopian tube, or peritoneal cancer who have responded to surgery and chemotherapy.
PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients with residual disease from stage III or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer following surgery and chemotherapy.
Detailed Description
OBJECTIVES: I. Compare the time to disease relapse, survival, and quality of life of patients with stage III or IV ovarian epithelial, tubal, or peritoneal adenocarcinoma treated with OvaRex monoclonal antibody B43.13 OR placebo following complete clinical response to primary therapy. II. Determine the safety of this regimen in these patients. III. Assess the immune response of patients treated with this regimen.
OUTLINE: This is a randomized study. Patients undergo a laparotomy and platinum based chemotherapy prior to randomization. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive OvaRex monoclonal antibody B43.13 IV on day 0. Treatment continues at 4, 8, 20, 32, 44, and 56 weeks, and then every 3 months in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive placebo IV on day 0. Placebo administration continues on the same schedule as in arm I. Patients presenting with relapse are provided with second line chemotherapy. Quality of life is assessed at the beginning of the study, after 2 months, and then every 3 months thereafter. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
oregovomab
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven stage III or IV ovarian epithelial, tubal, or peritoneal adenocarcinoma Must have had complete clinical response to primary therapy consisting of surgical debulking and platinum based chemotherapy Elevated CA 125 (greater than 35 U/mL) prior to or at surgery (if presurgical CA 125 measurement is not available, patient must have a serum CA 125 of at least 100 U/mL and strong tumor tissue expression) Must have residual disease (visible or palpable) at completion of the staging laparotomy (IIIB and IIIC microscopic disease)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 60-100% Life expectancy: At least 6 months Hematopoietic: Hemoglobin at least 8.0 g/dL Lymphocyte count at least 300/mm3 Neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.6 mg/dL
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy No prior murine monoclonal antibodies for diagnostic or therapeutic purposes Chemotherapy: No more than 1 prior regimen of chemotherapy (change in chemotherapy agents is permitted during primary therapy provided that the change is considered to be part of initial chemotherapy regimen) At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior abdominal, abdominopelvic, or pelvic radiotherapy Surgery: At least 4 weeks since prior surgery No more than 1 interval debulking procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan S. Berek, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0800
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Wilshire Oncology Medical Center
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5317
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Patty Berg Cancer Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
University of Florida Health Science Center - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Walt Disney Memorial Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Saint Mary's Hospital
City
East Saint Louis
State/Province
Illinois
ZIP/Postal Code
62201
Country
United States
Facility Name
Lutheran General Cancer Care Center
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Alton Ochsner Medical Foundation Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
New England Medical Center Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Minnesota Medical School
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Ellis Fischel Cancer Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Baptist Regional Cancer Center - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
University of Texas Southwestern Medical School
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9032
Country
United States
Facility Name
U.S. Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77060
Country
United States
Facility Name
Cancer Center, University of Virginia HSC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Swedish Hospital Tumor Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency - Fraser Valley Cancer Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Manitoba Cancer Treatment and Research Foundation
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Cancer Care Ontario-Hamilton Regional Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Credit Valley Hospital
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
Ottawa Regional Cancer Center - General Division
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Northeastern Ontario Regional Cancer Centre, Sudbury
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Centre Universitaire de Sante de l'Estrie
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W-W1T8
Country
Canada
Facility Name
Jewish General Hospital - Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Monoclonal Antibody Therapy in Treating Patients With Residual Disease From Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Following Surgery and Chemotherapy
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