NCT00377429

Brief Summary

The purpose of this study is to determine whether the investigational drug catumaxomab delivered in the planned treatment schedule is a safe and effective treatment for women with advanced ovarian cancer who experience a complete response to chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2 ovarian-cancer

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

July 11, 2012

Completed
Last Updated

July 19, 2012

Status Verified

July 1, 2012

Enrollment Period

1.4 years

First QC Date

September 15, 2006

Results QC Date

March 15, 2012

Last Update Submit

July 16, 2012

Conditions

Ovarian Cancer

Keywords

Epithelial CancerEpithelial CarcinomaEpithelial Ovarian CancerEpithelial Ovarian CarcinomaFallopian Tube CancerFallopian Tube CarcinomaOvarian CancerOvarian CarcinomaOvarian Epithelial CancerOvarian Epithelial CarcinomaPeritoneal CancerPeritoneal CarcinomaAdvanced Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days

    21 days

Secondary Outcomes (5)

  • Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy

    2 months

  • Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional)

    Baseline

  • Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)

    2 years

  • Number of Participants Who Survived (Post-study at 24 Month Visit)

    2 years

  • Number of Participants With no Residual Disease at 3 Months After Catumaxomab Treatment Via 3rd-look Laparoscopy or Laparotomy (These Procedures Are Optional)

    3 months

Study Arms (1)

catumaxomab

EXPERIMENTAL
Drug: catumaxomab

Interventions

catumaxomabDRUG

Catumaxomab administered as four 3-hour, constant-rate, intraperitoneal (IP) infusions of 10, 20, 50, 150 microgram (mcg).

Also known as: Removab
catumaxomab

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed and dated informed consent form before any protocol-specific screening procedures
  • Histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, FĂ©dĂ©ration Internationale de GynĂ©cologie et d'ObstĂ©trique (FIGO) stage IIb - IV
  • Optimal or sub-optimal cytoreductive surgery
  • Clinical complete response to platinum and taxane-based therapy consisting of at least four cycles, based on computed tomography (CT) scan and a CA-125 (cancer antigen 125) level below 35 U/mL
  • Age ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Last dose of platinum and taxane-based therapy completed within 6 weeks prior to the start of catumaxomab treatment
  • Negative serum pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility)
  • Willingness of patients of childbearing potential to use an effective contraceptive method (i.e. oral contraceptive, cervical cap, diaphragm with spermicide, condom with spermicide, or intrauterine device) during the study and for at least 6 months after the last infusion

You may not qualify if:

  • Acute or chronic systemic infection
  • Exposure to chemotherapy, radiotherapy, immunotherapy or investigational anti-cancer therapy within 6 weeks of first dose of catumaxomab other than last regimen of platinum and taxane chemotherapy as outlined in protocol
  • Known human immunodeficiency virus (HIV) infection
  • Previous treatment with non-humanized murine (rat or mouse) monoclonal antibodies (mAb)
  • Inadequate renal function (creatinine \> 1.5 x upper limit of normal \[ULN\])
  • Inadequate hepatic function:
  • Alanine aminotransferase (ALT) \> 2.5 x ULN or
  • Aspartate aminotransferase (AST) \> 2.5 x ULN or
  • Bilirubin \> 1.5 x ULN
  • Platelets \< 100,000 cells/mm\^3
  • Absolute neutrophil count (ANC) \< 1,500 cells/mm\^3
  • History of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within the last 6 months
  • No other malignancy within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix if adequately treated
  • No history of brain metastases
  • Any further condition or disease that would, in the opinion of the Investigator, expose the patient to undue risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Stanford University of Obstetrics and Gynecology

Stanford, California, 94305, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Gynecologic Oncology - Hinsdale

Hinsdale, Illinois, 60521, United States

Location

Michiana Hematology Oncology P.C.

South Bend, Indiana, 46617, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Magee-Women Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

South Carolina Oncology Associates

Columbia, South Carolina, 29210, United States

Location

Related Publications (5)

  • Heiss MM, Strohlein MA, Jager M, Kimmig R, Burges A, Schoberth A, Jauch KW, Schildberg FW, Lindhofer H. Immunotherapy of malignant ascites with trifunctional antibodies. Int J Cancer. 2005 Nov 10;117(3):435-43. doi: 10.1002/ijc.21165.

    PMID: 15906359BACKGROUND

  • Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.

    PMID: 11588051BACKGROUND

  • Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7. doi: 10.1177/002215540104900711.

    PMID: 11410615BACKGROUND

  • Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237.

    PMID: 10901380BACKGROUND

  • Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.

    PMID: 10415020BACKGROUND

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinomaCarcinoma, Ovarian EpithelialFallopian Tube Neoplasms

Interventions

catumaxomab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeFallopian Tube Diseases

Results Point of Contact

Title
Anne Kuan
Organization
Fresenius Biotech
anne.kuan@fresenius-biotech.com
781 699 4618

Study Officials

  • Michael V Seiden, MD, Ph.D

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2006

First Posted

September 18, 2006

Study Start

September 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

July 19, 2012

Results First Posted

July 11, 2012

Record last verified: 2012-07

Locations

US(12)