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Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006089
First received: August 3, 2000
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. 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 Adenocarcinoma
Recurrent Endometrial Carcinoma
Stage III Endometrial Carcinoma
Stage IV Endometrial Carcinoma
 Biological: trastuzumab
Other: laboratory biomarker analysis
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

Drug Information available for: Trastuzumab
U.S. FDA Resources

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

Primary Outcome Measures:
  • Frequency and duration of objective response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency and severity of observed adverse effects assessed using Common Terminology Criteria (CTC) version 2.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Time Frame: From study entry until disease progression, death or date or last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    Will be evaluated with non-parametric statistics (such as the log-rank test) through comparisons with the historical controls.

  • Duration of overall survival [ Time Frame: From study entry to death or date or last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    Will be evaluated with non-parametric statistics (such as the log-rank test) through comparisons with the historical controls.

  • Prognostic factors (i.e., initial performance status and histological grade) [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
    Comparisons will be made through a Cox model, which allows for adjustments with the prognostic variables.


Enrollment: 42
Study Start Date: March 2001
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (trastuzumab)
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.
 Biological: trastuzumab
Given IV
Other Names:
  • anti-c-erB-2
  • Herceptin
  • MOAB HER2
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OOBJECTIVES:

I. 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.

II. Determine the toxicity of this regimen in these patients.

SECONDARY OBJECTIVES:

I. Determine the progression-free and overall survival of patients treated with this regimen.

II. 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

Inclusion Criteria:

  • 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
  • Performance status - GOG 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Creatinine ≤ 1.5 times ULN
  • 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
  • No requirement for supplemental oxygen at rest or with ambulation
  • 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
  • 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
  • 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
  • At least 1 week since prior hormonal therapy directed at the malignant tumor

  • No concurrent hormonal therapy

    • Continuation of hormone replacement therapy allowed
  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy for the malignant tumor and recovered
  • No concurrent radiotherapy
  • Recovered from prior recent surgery
  • 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

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Gini Fleming Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006089     History of Changes
Other Study ID Numbers: NCI-2012-02356, GOG-0181-B, U10CA027469, CDR0000068091
Study First Received: August 3, 2000
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma
Adenoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Uterine Neoplasms
 Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013