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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006903
First received: December 6, 2000
Last updated: November 17, 2010
Last verified: October 2008
  Purpose

RATIONALE: 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.

PURPOSE: This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent, persistent, or metastatic endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Drug: fulvestrant
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Faslodex In Recurrent/Metastatic Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical response by RECIST criteria evaluated every 8 weeks [ Designated as safety issue: No ]
  • Clinical response by RECIST criteria and intensity of estrogen receptor expression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity of fulvestrant by Common Toxicity Criteria [ Designated as safety issue: Yes ]
  • Disease-free and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 95
Study Start Date: August 2004
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-1

Life expectancy:

  • Not specified

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered

Surgery:

  • See Disease Characteristics
  • At least 3 weeks since prior surgery and recovered
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006903

  Show 52 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Allan Covens, MD Edmond Odette Cancer Centre at Sunnybrook
  More Information

Additional Information:
Publications:
Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00006903     History of Changes
Other Study ID Numbers: CDR0000068339, GOG-0188
Study First Received: December 6, 2000
Last Updated: November 17, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV endometrial carcinoma
recurrent endometrial carcinoma
stage III endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Fulvestrant
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on April 17, 2014