Clinical trial NCT00006089: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Adenocarcinoma
ERBB2 Gene Amplification
Recurrent Uterine Corpus Carcinoma
Stage III Uterine Corpus Cancer AJCC v7
Stage IV Uterine Corpus Cancer AJCC v7
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: Gynecologic Oncology Group
First posted: 2003-01-27
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency and duration of objective response
timeFrame: Up to 5 years
measure: Frequency and severity of observed adverse effects assessed using Common Terminology Criteria (CTC) version 2.0
timeFrame: Up to 5 years
Secondary outcomes:
measure: Duration of progression-free survival
timeFrame: From study entry until disease progression, death or date or last contact, assessed up to 5 years
measure: Duration of overall survival
timeFrame: From study entry to death or date or last contact, assessed up to 5 years
measure: Prognostic factors (i.e., initial performance status and histological grade)
timeFrame: Not Provided
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: Gini F Fleming
role: PRINCIPAL_INVESTIGATOR
References: