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Phase II Study of Faslodex In Recurrent/Metastatic Endometrial Cancer

Phase 2
Open (Enrolling)
Endometrial Cancer

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Trial Information

Phase II Study of Faslodex In Recurrent/Metastatic Endometrial Cancer


- Compare the probability of clinical response in estrogen receptor (ER)-positive vs
ER-negative patients with recurrent, persistent, or metastatic endometrial cancer
treated with fulvestrant.

- Compare the relationship between response rate and intensity of receptor expression in
patients treated with this drug.

- Determine the frequency and intensity of toxicity of this drug in these patients.

OUTLINE: Patients receive fulvestrant intramuscularly on day 1. Treatment repeats every 28
days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

Inclusion Criteria


- Histologically confirmed recurrent, persistent, or metastatic endometrial cancer that
is not curable with surgery or radiotherapy

- Estrogen receptor (ER) and progesterone receptor status known by immunohistochemistry

- ER positive or negative allowed

- Measurable disease

- At least 1 target lesion not within a previously irradiated field OR irradiated
target lesion with clear disease progression

- At least 20 mm by conventional techniques, including palpation, x-ray, CT scan,
MRI, OR at least 10 mm by spiral CT scan



- Not specified

Performance status:

- GOG 0-1

Life expectancy:

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥100,000/mm^3

- No prior bleeding diathesis (disseminated intravascular coagulation, clotting factor
deficiency, or requirement for anticoagulants)


- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 3 times ULN

- Alkaline phosphatase ≤ 3 times ULN


- Creatinine ≤ 2 mg/dL


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No hypersensitivity to castor oil

- No other concurrent malignancy except nonmelanoma skin cancer

- No other prior malignancy within past 5 years


Biologic therapy:

- Not specified


- No prior chemotherapy for persistent, recurrent, or metastatic endometrial cancer

- No more than 1 prior chemotherapy regimen for newly diagnosed endometrial cancer that
has subsequently recurred

Endocrine therapy:

- At least 3 weeks since prior hormonal therapy and recovered


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered


- See Disease Characteristics

- At least 3 weeks since prior surgery and recovered

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response by RECIST criteria evaluated every 8 weeks

Safety Issue:


Principal Investigator

Allan Covens, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Edmond Odette Cancer Centre at Sunnybrook


United States: Federal Government

Study ID:




Start Date:

August 2004

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • stage III endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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