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

Endometrial Adenocarcinoma Clinical Trial

Official title:

A Phase II Evaluation of Trastuzumab (MoAb HER2) in Patients With Advanced, Recurrent or Persistent Endometrial Carcinoma With or Without Prior Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006089
• Other study ID #: NCI-2012-02356
• Secondary ID: NCI-2012-02356CD
• Status: Completed
• Phase: Phase 2
• Start date: September 18, 2000
• Est. completion date: January 31, 2010

Study information

• Verified date: July 2019
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 31, 2010
• Est. primary completion date: September 4, 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Endometrial Adenocarcinoma
• ERBB2 Gene Amplification
• Recurrent Uterine Corpus Carcinoma
• Stage III Uterine Corpus Cancer AJCC v7
• Stage IV Uterine Corpus Cancer AJCC v7
• Uterine Neoplasms

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Biological:
• Trastuzumab
Given IV

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	Gynecologic Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and duration of objective response		Up to 5 years
Primary	Frequency and severity of observed adverse effects assessed using Common Terminology Criteria (CTC) version 2.0		Up to 5 years
Secondary	Duration of progression-free survival	Will be evaluated with non-parametric statistics (such as the log-rank test) through comparisons with the historical controls.	From study entry until disease progression, death or date or last contact, assessed up to 5 years
Secondary	Duration of overall survival	Will be evaluated with non-parametric statistics (such as the log-rank test) through comparisons with the historical controls.	From study entry to death or date or last contact, assessed up to 5 years
Secondary	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.	Not Provided