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Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
This study is ongoing, but not recruiting participants.
First Received: August 3, 2000   Last Updated: October 29, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006089
  Purpose

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage III, stage IV, or recurrent endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Biological: trastuzumab
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evaluation of Trastuzumab (MoAb HER2) in Patients With Advanced, Recurrent or Persistent Endometrial Carcinoma With or Without Prior Chemotherapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Frequency and duration of objective response [ Designated as safety issue: No ]
  • The frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free survival and overall survival [ Designated as safety issue: No ]
  • Prognostic factors (i.e., initial performance status and histological grade) [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: March 2001
Detailed Description:

OBJECTIVES:

Primary

  • Determine the antitumor activity of trastuzumab (Herceptin®), in terms of response, in patients with advanced, recurrent, or persistent endometrial adenocarcinoma that demonstrates HER2/neu gene amplification by fluorescent in situ hybridization.
  • Determine the toxicity of this regimen in these patients.

Secondary

  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the effects of prognostic factors (i.e., initial performance status and histological grade) in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 25-42 patients will be accrued for this study within 12 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed endometrial adenocarcinoma

    • Advanced, recurrent, or persistent disease
    • Refractory to curative therapy
  • HER2/neu gene amplification by fluorescent in situ hybridization
  • Measurable disease

    • Previously irradiated field as sole site of measurable disease allowed if evidence of progression since completion of radiotherapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic:

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)

Renal:

  • Creatinine ≤ 1.5 times ULN

Cardiovascular:

  • LVEF ≥ 45% by echocardiogram or MUGA
  • History of coronary artery disease and/or congestive heart failure allowed if medical management of condition has been stable within the past 6 months
  • No active or unstable cardiac disease
  • No active angina
  • No myocardial infarction within the past 6 months

Pulmonary:

  • No requirement for supplemental oxygen at rest or with ambulation

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No uncontrolled infection
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No other unstable medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior biologic and immunologic agents directed at the malignant tumor
  • No prior anti-HER2 monoclonal antibody preparation
  • No other concurrent immunotherapy

Chemotherapy:

  • Recovered from prior chemotherapy
  • Multiple prior chemotherapy regimens allowed
  • No more than 320 mg/m^2 total dose of prior doxorubicin allowed (including doxorubicin HCl liposome or other liposomally encapsulated doxorubicin preparations)
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  • No concurrent hormonal therapy

    • Continuation of hormone replacement therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy for the malignant tumor and recovered
  • No concurrent radiotherapy

Surgery:

  • Recovered from prior recent surgery

Other

  • At least 3 weeks since any prior therapy directed at the malignant tumor
  • No prior cancer treatment that would contraindicate study therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006089

  Hide Study Locations
Locations
United States, Arizona
Banner Baywood Medical Center
Mesa, Arizona, United States, 85206
Banner Desert Medical Center
Mesa, Arizona, United States, 85202
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
Banner Thunderbird Medical Center
Glendale, Arizona, United States, 85306
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach, California, United States, 90801
United States, Colorado
McKee Medical Center
Loveland, Colorado, United States, 80539
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Rocky Mountain Gynecologic Oncology
Englewood, Colorado, United States, 80110
United States, District of Columbia
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
United States, Illinois
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
Rush University Medical Center
Chicago, Illinois, United States, 60612
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
St. Anthony's Memorial Hospital
Effingham, Illinois, United States, 62401
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States, 47374
Howard Community Hospital at Howard Regional Health System
Kokomo, Indiana, United States, 46904
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Louisville Oncology at Norton Cancer Center
Louisville, Kentucky, United States, 40202
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States, 02111
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
St. Joseph, Michigan, United States, 49085
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710-1799
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
CCOP - Dayton
Dayton, Ohio, United States, 45429
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grandview Hospital
Dayton, Ohio, United States, 45405
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
United States, Virginia
Carilion Gynecologic Oncology Associates
Roanoke, Virginia, United States, 24014
University of Virginia Cancer Center at UV Health System
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Gini F. Fleming, MD University of Chicago
  More Information

Additional Information:
Publications:
Fleming GF, Sill MW, Darcy KM, McMeekin DS, Thigpen JT, Adler LM, Berek JS, Chapman JA, Disilvestro PA, Horowitz IR, Fiorica JV. Phase II trial of trastuzumab in women with advanced or recurrent, HER2-positive endometrial carcinoma: A Gynecologic Oncology Group study. Gynecol Oncol. 2009 Oct 17; [Epub ahead of print]
Fleming GF, Sill MA, Thigpen JT, et al.: Phase II evaluation of trastuzumab in patients with advanced or recurrent endometrial carcinoma: a report on GOG 181B . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1821, 453, 2003.

Study ID Numbers: CDR0000068091, GOG-0181-B
Study First Received: August 3, 2000
Last Updated: October 29, 2009
ClinicalTrials.gov Identifier: NCT00006089     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage III endometrial carcinoma
stage IV endometrial carcinoma
recurrent endometrial carcinoma
endometrial adenocarcinoma

Additional relevant MeSH terms:
Genital Diseases, Female
Neoplasms
Endometrial Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Trastuzumab
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009