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

Completed · Phase 2

Conditions studied: Endometrial Adenocarcinoma, ERBB2 Gene Amplification, Recurrent Uterine Corpus Carcinoma, Stage III Uterine Corpus Cancer AJCC v7, Stage IV Uterine Corpus Cancer AJCC v7

In brief

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.

Key facts

Study ID

NCT00006089

Run by

National Cancer Institute (NCI)

People needed

34

Starts

2000-09-18

Expected to finish

2010-01-31

Last updated by the study team

2019-07-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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