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


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Adenocarcinoma, Recurrent Endometrial Carcinoma, Stage III Endometrial Carcinoma, Stage IV Endometrial Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Gini Fleming

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02356

NCT ID:

NCT00006089

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Endometrial Adenocarcinoma
  • Recurrent Endometrial Carcinoma
  • Stage III Endometrial Carcinoma
  • Stage IV Endometrial Carcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Adenoma
  • Endometrial Neoplasms

Name

Location

Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103