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

NCT ID: NCT00006089

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-18
• Study Completion Date: 2010-01-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Trastuzumab

Intervention Type: BIOLOGICAL

Given IV

Interventions

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Trastuzumab

Given IV

Intervention Type: BIOLOGICAL

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynecologic Oncology Group

NETWORK

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gini F Fleming

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-02356

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000068091

Identifier Type: -

Identifier Source: secondary_id

GOG-0181B

Identifier Type: -

Identifier Source: secondary_id

GOG-0181-B

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0181B

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-02356

Identifier Type: -

Identifier Source: org_study_id