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

Primary Purpose

Endometrial Adenocarcinoma, ERBB2 Gene Amplification, Recurrent Uterine Corpus Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Trastuzumab
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (trastuzumab)

Arm Description

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.

Outcomes

Primary Outcome Measures

Frequency and duration of objective response
Frequency and severity of observed adverse effects assessed using Common Terminology Criteria (CTC) version 2.0

Secondary Outcome Measures

Duration of progression-free survival
Will be evaluated with non-parametric statistics (such as the log-rank test) through comparisons with the historical controls.
Duration of overall survival
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)
Comparisons will be made through a Cox model, which allows for adjustments with the prognostic variables.

Full Information

First Posted
August 3, 2000
Last Updated
July 30, 2019
Sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00006089
Brief Title
Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Official Title
A Phase II Evaluation of Trastuzumab (MoAb HER2) in Patients With Advanced, Recurrent or Persistent Endometrial Carcinoma With or Without Prior Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 18, 2000 (Actual)
Primary Completion Date
September 4, 2007 (Actual)
Study Completion Date
January 31, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Adenocarcinoma, ERBB2 Gene Amplification, Recurrent Uterine Corpus Carcinoma, Stage III Uterine Corpus Cancer AJCC v7, Stage IV Uterine Corpus Cancer AJCC v7

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (trastuzumab)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Biological
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
ABP 980, ALT02, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2, Anti-erbB-2, Anti-erbB2 Monoclonal Antibody, Anti-HER2/c-erbB2 Monoclonal Antibody, Anti-p185-HER2, c-erb-2 Monoclonal Antibody, HER2 Monoclonal Antibody, Herceptin, Herceptin Biosimilar PF-05280014, Herceptin Trastuzumab Biosimilar PF-05280014, Herzuma, MoAb HER2, Monoclonal Antibody c-erb-2, Monoclonal Antibody HER2, Ogivri, Ontruzant, PF-05280014, rhuMAb HER2, RO0452317, Trastuzumab Biosimilar ABP 980, Trastuzumab Biosimilar ALT02, trastuzumab biosimilar EG12014, Trastuzumab Biosimilar HLX02, Trastuzumab Biosimilar PF-05280014, Trastuzumab-dkst, Trastuzumab-DTTB, Trastuzumab-pkrb, Trastuzumab-QYYP, Trazimera
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Frequency and duration of objective response
Time Frame
Up to 5 years
Title
Frequency and severity of observed adverse effects assessed using Common Terminology Criteria (CTC) version 2.0
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Duration of progression-free survival
Description
Will be evaluated with non-parametric statistics (such as the log-rank test) through comparisons with the historical controls.
Time Frame
From study entry until disease progression, death or date or last contact, assessed up to 5 years
Title
Duration of overall survival
Description
Will be evaluated with non-parametric statistics (such as the log-rank test) through comparisons with the historical controls.
Time Frame
From study entry to death or date or last contact, assessed up to 5 years
Title
Prognostic factors (i.e., initial performance status and histological grade)
Description
Comparisons will be made through a Cox model, which allows for adjustments with the prognostic variables.
Time Frame
Not Provided

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gini F Fleming
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

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

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