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

NCT ID: NCT00006903

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-30

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (fulvestrant)

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.

Group Type: EXPERIMENTAL

Fulvestrant

Intervention Type: DRUG

Given intramuscularly

Interventions

Fulvestrant

Given intramuscularly

Intervention Type: DRUG

Other Intervention Names

Faslodex; Faslodex(ICI 182,780); ICI 182,780; ICI 182780; ZD9238

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allan L Covens

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Other Identifiers

NCI-2009-00581

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000068339

Identifier Type: -

Identifier Source: secondary_id

GOG-0188

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0188

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-0188

Identifier Type: -

Identifier Source: org_study_id