Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer

Gynecologic Oncology Group (GOG)

Status and phase: Unknown; Phase 2

Conditions: Stage IV Uterine Corpus Cancer AJCC v7; Stage III Uterine Corpus Cancer AJCC v7; Recurrent Uterine Corpus Carcinoma

Treatments: Drug: Fulvestrant

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00006903

U10CA027469 (U.S. NIH Grant/Contract)

U10CA180868 (U.S. NIH Grant/Contract)

NCI-2009-00581 (Registry Identifier)

GOG-0188 (Other Identifier)

CDR0000068339

Details and patient eligibility

About

This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent, persistent, or metastatic endometrial cancer. Estrogen can stimulate the growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells.

Full description

PRIMARY OBJECTIVES:

I. 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.

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

III. 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 up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Enrollment: 67 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

• Performance status:

  • GOG 0-1

• Hematopoietic:

  • 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)

• Hepatic:

  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • SGOT =< 3 times ULN
  • Alkaline phosphatase =< 3 times ULN

• Renal:

  • 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

• 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

• At least 3 weeks since prior hormonal therapy and recovered

• At least 3 weeks since prior radiotherapy and recovered

• At least 3 weeks since prior surgery and recovered

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Treatment (fulvestrant)

Experimental group

Description:

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.

Treatment:

Drug: Fulvestrant