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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborators: AstraZeneca; National Cancer Institute (NCI)
• Treatments: Estradiol; Fulvestrant

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