Ovarian CancerPhase 3NCT00050375
Clinical Trial for Ovarian Cancer (OvaRex®)
A Phase 3 study testing oregovomab in people with Ovarian Cancer, run by Unither Pharmaceuticals at 62 sites in United States.
Trial summary
This study will compare the time to disease relapse between OvaRex® MAb-B43.13-treated patients and placebo-treated patients. This study will also compare assessments of survival, quality of life, immune response and safety between active and placebo groups. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- oregovomab
- How many people
- 354 participants
- Where
- 62 sitesUnited States
- Study dates
- Dec 2002to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin, and their disease is classified as FIGO Stage III or IV. Histological diagnosis must have been confirmed by site pathology review of slides as documented by the site investigator. These slides must be made available for sponsor review.
- Patients must have had an elevated serum CA125 level (per reference lab normal range) measured prior to or at surgery (i.e., not later than the immediate post-surgery period when the patient is in the surgical recovery room). If a pre-surgical CA125 measurement is not available, then the patient must have had: (a) a serum CA125 level ≥100 U/mL, and (b) tumor tissue that has been demonstrated by immunohistochemical methods to express CA125.
- Patients must have had a documented serum CA125 level ≤65 U/mL prior to the third cycle of front-line chemotherapy.
- Patients must have had microscopic or small diameter residual disease following primary de-bulking surgical procedure.
- Patients must have received chemotherapy that included a platinum compound and a taxane following appropriate staging procedures. Front-line treatment can include no more than 8 cycles of chemotherapy.
- Patients must have had a complete clinical response to their front-line surgery and chemotherapy. A complete clinical response is defined as one in which the patient had a normal physical examination, no conclusive evidence of residual tumor by CT of the abdomen and pelvis, a normal chest x-ray, and a serum CA125 level at least 5 U/mL but less than 35 U/mL as measured in the pretreatment baseline laboratories by the protocol Central Lab.
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- Patients must have undergone no more than one interval de-bulking procedure.
- Patients must receive their first dose of study medication between 4 and 12 weeks after completing their last dose of front-line chemotherapy.
- Patients must have voluntarily agreed to participate and have signed the informed consent, and are willing to complete all study procedures.
Who cannot join
- Patients who have received more than one prior regimen of chemotherapy. A change in chemotherapy agents is permitted during the patient's primary therapy provided that the change is considered to be part of the initial chemotherapy treatment regimen.
- Patients with known refractory or recurrent epithelial adenocarcinoma of ovarian, tubal, or peritoneal origin requiring chemotherapy.
- Patients who have compromised hematopoietic function (hemoglobin <8.0 g/dL; lymphocyte count <300 mm³; neutrophil count <1000 mm³; platelet count <100,000 mm³.
- Patients with hepatic dysfunction defined as a bilirubin >1.5 times the upper normal limits, LDH, SGOT and SGPT>2 times upper limits of normal or albumin <3.5 g/dL.
- Patients with severe renal dysfunction defined as a serum creatinine >1.6 mg/dL.
- Patients with a known allergy to murine proteins or have had a documented anaphylactic reaction to any drug, or a known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure.
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- Patients who have contraindications to the use of pressor agents.
- Patients being chronically treated with immunosuppressive drugs such as cyclosporin, ACTH, or systemic corticosteroids.
- Patients who have received immunotherapy (interferons, tumor necrosis factor, other cytokines [e.g., interleukins] or biological response modifiers, or BCG vaccines) within 6 weeks of receiving their first dose of study medication. Patients who have received hemopoietic factors are acceptable.
- Patients who have had a splenectomy.
- Patients with uncontrolled diseases other than cancer will be excluded. Patients with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are eligible.
- Patients who have a concurrent illness or chronically taking medication, which would confound the results of the study, preclude the patient from completing the study, or mask an adverse reaction.
- Patients who have a concurrent malignancy (except non-melanoma of the skin, in situ carcinoma of cervix), unless the patient received curative treatment and has been disease free for greater than or equal to 5 years.
- Patients receiving other investigational drugs within 30 days of enrollment.
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
United States62 sites
Arlington Cancer Center
Arlington, Texas, 76012
Medical College of Georgia
Augusta, Georgia, 30912
Southwest Regional Cancer Center
Austin, Texas, 78705
The Harry and Jeanette Weinberg Cancer Institute
Baltimore, Maryland, 21237-3998
New England Medical Center
Boston, Massachusetts, 02111
Blumenthal Cancer Center
Charlotte, North Carolina, 28203
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Chattanooga GYN Oncology
Chattanooga, Tennessee, 37403
The University of Chicago Hospitals
Chicago, Illinois, 60637
University Hospital - Health Systems
Cleveland, Ohio, 44106
Ellis Fischel Cancer Center
Columbia, Missouri, 65203
South Carolina Oncology Associates
Columbia, South Carolina, 29203
GYN Oncology and Pelvic Surgery Associates
Columbus, Ohio, 43222
Univ. of Texas SW Medical Center at Dallas
Dallas, Texas, 75235-9032
Texas Oncology, PA
Dallas, Texas, 75246-2006
Rocky Mountain Cancer Center-Midtown
Denver, Colorado, 80218
Duke University Medical Center
Durham, North Carolina, 27710
University of Connecticut Cancer Center
Farmington, Connecticut, 06030
Florida Gynecologic Oncology
Fort Myers, Florida, 33901
Texas Oncology
Fort Worth, Texas, 76104
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
St. Jude Medical Center
Fullerton, California, 92835
Gynecologic Oncology Research and Development
Greenville, South Carolina, 29601
Comprehensive Cancer Institute
Huntsville, Alabama, 35801
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, 46260
Women's Specialty Center
Jackson, Mississippi, 39202
Wilshire Oncology Medical Group
La Verne, California, 91750
Lake Charles Medical Surgical Clinic
Lake Charles, Louisiana, 70601
Little Rock Hematology Oncology Assoc.
Little Rock, Arkansas, 72205
Cedars-Sinai Medical Center
Los Angeles, California, 90048
UCLA School of Medicine
Los Angeles, California, 90095-1740
Brown Cancer Center
Louisville, Kentucky, 40202
Louisville Oncology
Louisville, Kentucky, 40202
North Shore University Hospital
Manhasset, New York, 11030
West Clinic, PC
Memphis, Tennessee, 38120
Jersey Shore Medical Center
Neptune City, New Jersey, 07754
Hematology and Oncology Specialists
New Orleans, Louisiana, 70115
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011
Gynecologic Oncology Associates
Newport Beach, California, 92663
VA Oncology Associates
Norfolk, Virginia, 23502
Nyack Hospital
Nyack, New York, 10960
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of California, Irvine
Orange, California, 92868
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Pensacola Research Consultants
Pensacola, Florida, 32504
Western Regional Community Clinical Oncology Program
Phoenix, Arizona, 85006
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213-3180
Northwest Cancer Specialists-Northrup
Portland, Oregon, 97210
Brown University School of Medicine
Providence, Rhode Island, 02905
Carilion GYN Oncology Associates
Roanoke, Virginia, 24014
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Sharp Memorial Hospital
San Diego, California, 92123
Swedish Medical Center
Seattle, Washington, 98104
Michiana Hematology Oncology PC
South Bend, Indiana, 46617
Cancer Care Northwest
Spokane, Washington, 99218
Stanford University
Stanford, California, 94305
SUNY-HSC Syracuse, Crouse Hospital
Syracuse, New York, 13210
H. Lee Moffitt Cancer Center and Research
Tampa, Florida, 33612-9497
ProMedica Health Systems
Toledo, Ohio, 43606
Medical College of Ohio Cancer Institute
Toledo, Ohio, 43614-5809
Northwestern Connecticut Oncology Hematology Associates, LLP
Torrington, Connecticut, 06790
Northwest Cancer Specialists-Vancouver
Vancouver, Washington, 98684
About this study
Official title: A Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of Intravenous OvaRex® MAb-B43.13 as Post Chemotherapy Consolidation for Epithelial Carcinoma of Ovarian, Tubal or Peritoneal Origin
This study will compare the time to disease relapse between OvaRex® MAb-B43.13-treated patients and placebo-treated patients. This study will also compare assessments of survival, quality of life, immune response and safety between active and placebo groups.
Read the detailed description
This a Phase III, double-blind, placebo-controlled, multi-center study of intravenous OvaRex® MAb-B43.13 as post-chemotherapy consolidation for epithelial carcinoma of ovarian, tubal, or peritoneal origin.
- Conditions
- Ovarian Cancer
- Being tested
- oregovomab
- Keywords
- OvaRex, ovarian, CA125, murine, antibody, immunotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oregovomabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2002 (estimated)
- Study startDec 2002
- Study completionDec 2007
Why it stopped: Study closed by sponser
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 354 participants
Sponsor and investigators
- Lead sponsor
- Unither Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050375
- Sponsor's protocol ID
- OVA-Gy-17
- Status last verified
- Jun 2006
- First submitted
- 5 Dec 2002
- Last updated
- 18 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of Intravenous OvaRex® MAb-B43.13 as Post Chemotherapy Consolidation for Epithelial Carcinoma of Ovarian, Tubal or Peritoneal Origin
- ClinicalTrials.gov ID
- NCT00050375
- Acronym / sponsor ID
- OVA-Gy-17
- Conditions
- Ovarian Cancer
- Keywords
- OvaRex, ovarian, CA125, murine, antibody, immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed by sponser
- Enrolment
- 354 participants
- Lead sponsor
- Unither PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the time to disease relapse between OvaRex® MAb-B43.13-treated patients and placebo-treated patients. This study will also compare assessments of survival, quality of life, immune response and safety between active and placebo groups.
Detailed description
This a Phase III, double-blind, placebo-controlled, multi-center study of intravenous OvaRex® MAb-B43.13 as post-chemotherapy consolidation for epithelial carcinoma of ovarian, tubal, or peritoneal origin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have a histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin, and their disease is classified as FIGO Stage III or IV. Histological diagnosis must have been confirmed by site pathology review of slides as documented by the site investigator. These slides must be made available for sponsor review.
- Patients must have had an elevated serum CA125 level (per reference lab normal range) measured prior to or at surgery (i.e., not later than the immediate post-surgery period when the patient is in the surgical recovery room). If a pre-surgical CA125 measurement is not available, then the patient must have had: (a) a serum CA125 level ≥100 U/mL, and (b) tumor tissue that has been demonstrated by immunohistochemical methods to express CA125.
- Patients must have had a documented serum CA125 level ≤65 U/mL prior to the third cycle of front-line chemotherapy.
- Patients must have had microscopic or small diameter residual disease following primary de-bulking surgical procedure.
- Patients must have received chemotherapy that included a platinum compound and a taxane following appropriate staging procedures. Front-line treatment can include no more than 8 cycles of chemotherapy.
Key exclusion criteria (14 listed)
- Patients who have received more than one prior regimen of chemotherapy. A change in chemotherapy agents is permitted during the patient's primary therapy provided that the change is considered to be part of the initial chemotherapy treatment regimen.
- Patients with known refractory or recurrent epithelial adenocarcinoma of ovarian, tubal, or peritoneal origin requiring chemotherapy.
- Patients who have compromised hematopoietic function (hemoglobin <8.0 g/dL; lymphocyte count <300 mm³; neutrophil count <1000 mm³; platelet count <100,000 mm³.
- Patients with hepatic dysfunction defined as a bilirubin >1.5 times the upper normal limits, LDH, SGOT and SGPT>2 times upper limits of normal or albumin <3.5 g/dL.
- Patients with severe renal dysfunction defined as a serum creatinine >1.6 mg/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oregovomab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Study closed by sponser). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oregovomab in people with Ovarian Cancer, run by Unither Pharmaceuticals at 62 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study closed by sponser). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2007.