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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006903
First Posted: January 27, 2003
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
  Purpose
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.

Condition Intervention Phase
Recurrent Uterine Corpus Carcinoma Stage III Uterine Corpus Cancer Stage IV Uterine Corpus Cancer Drug: Fulvestrant Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Faslodex ® in Recurrent/Metastatic Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks [ Time Frame: Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment. ]

    Primary outcome measured according to RECIST v1.0 Best Response:

    Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart

    Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

    Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required

    Stable Disease is any condition not meeting the above criteria.

    Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.


  • Clinical Response by RECIST Criteria of Estrogen Receptor Expression [ Time Frame: Every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment. ]

Secondary Outcome Measures:
  • Toxicity of Fulvestrant by Common Toxicity Criteria [ Time Frame: During study treatment and up to 30 days after stopping study ]

Enrollment: 67
Study Start Date: August 2004
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Fulvestrant
Given intramuscularly
Other Names:
  • Faslodex
  • Faslodex(ICI 182,780)
  • ICI 182,780
  • ICI 182780
  • ZD9238

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006903


Locations
United States, Pennsylvania
NRG Oncology
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Allan Covens NRG Oncology
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00006903     History of Changes
Other Study ID Numbers: GOG-0188
NCI-2009-00581 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000068339
GOG-0188 ( Other Identifier: NRG Oncology )
GOG-0188 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: December 6, 2000
First Posted: January 27, 2003
Results First Submitted: May 20, 2014
Results First Posted: June 24, 2014
Last Update Posted: May 31, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Carcinoma
Uterine Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Fulvestrant
Estradiol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones