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Fallopian Tube CancerPhase 2NCT00003634

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

A Phase 2 study testing oregovomab in people with Fallopian Tube Cancer and Ovarian Cancer, run by AltaRex at 46 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
oregovomab
How many people
400 participants
Where
46 sitesin 2 countries
Study dates
Apr 1998to not given
Phase
Phase 2
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

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

Trial locations and contacts

46 sites in 2 countries.

46 sites in 2 countries

United States29 sites

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • New England Medical Center Hospital

    Boston, Massachusetts, 02111

  • Cancer Center, University of Virginia HSC

    Charlottesville, Virginia, 22908

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637

  • Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • University of Texas Southwestern Medical School

    Dallas, Texas, 75235-9032

  • University of Colorado Cancer Center

    Denver, Colorado, 80262

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Saint Mary's Hospital

    East Saint Louis, Illinois, 62201

  • Patty Berg Cancer Center

    Fort Myers, Florida, 33901

  • U.S. Oncology

    Houston, Texas, 77060

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Florida Health Science Center - Jacksonville

    Jacksonville, Florida, 32209

  • Baptist Regional Cancer Center - Knoxville

    Knoxville, Tennessee, 37901

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033-0800

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • North Shore University Hospital

    Manhasset, New York, 11030

  • University of Minnesota Medical School

    Minneapolis, Minnesota, 55455

  • Alton Ochsner Medical Foundation Hospital

    New Orleans, Louisiana, 70121

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73190

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Walt Disney Memorial Cancer Institute

    Orlando, Florida, 32804

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068

  • Wilshire Oncology Medical Center

    Pomona, California, 91767

  • Swedish Hospital Tumor Institute

    Seattle, Washington, 98104

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Stanford University School of Medicine

    Stanford, California, 94305-5317

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

Other trials in United States

Canada17 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Centre Universitaire de Sante de l'Estrie

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2W-W1T8

  • Jewish General Hospital - Montreal

    Montreal, Quebec, H3T 1E2

  • Ottawa Regional Cancer Center - General Division

    Ottawa, Ontario, K1H 8L6

  • Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec

    Québec, Quebec, G1R 2J6

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • British Columbia Cancer Agency - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • Manitoba Cancer Treatment and Research Foundation

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Double-Blind Placebo Controlled Trial of Intravenous OvaRex MAb-B43.13 as Post Chemotherapy Consolidation for Ovarian Tubal and Peritoneal Carcinoma

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.

Read the 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.

Being tested
oregovomab
Keywords
stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oregovomabBiological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2004 (estimated)
  2. Study startApr 1998

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003634
Sponsor's protocol ID
CDR0000066718
Other IDs
ALTAREX-OVA-Gy-07, ALTAREX-961452, ALTAREX-OVA-Gy-06, NCI-V98-1488
Status last verified
May 2007
First submitted
1 Nov 1999
Last updated
6 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oregovomab in people with Fallopian Tube Cancer and Ovarian Cancer, run by AltaRex at 46 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

On the ClinicalTrials.gov record for NCT00003634.

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 6 Nov 2013.

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