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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: February 6, 2009   History of Changes
Sponsors and Collaborators: Gynecologic Oncology Group
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

MedlinePlus related topics: Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources
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

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

  Show 76 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Gini F. Fleming, MD University of Chicago
  More Information

Additional Information:
Publications:
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: February 6, 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

Study placed in the following topic categories:
Genital Diseases, Female
Endometrial Neoplasms
Trastuzumab
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Endometrial Cancer
Urogenital Neoplasms
Adenocarcinoma
Recurrence
Carcinoma

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 May 06, 2009