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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Astra Zenca
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00006903
First received: December 6, 2000
Last updated: May 20, 2014
Last verified: May 2014
  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 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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]

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

Enrollment: 67
Study Start Date: August 2004
Primary Completion Date: November 2010 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006903

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

Additional Information:
Publications:
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00006903     History of Changes
Other Study ID Numbers: GOG-0188, GOG-0188, CDR0000068339
Study First Received: December 6, 2000
Results First Received: May 20, 2014
Last Updated: May 20, 2014
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
stage IV endometrial carcinoma
recurrent endometrial carcinoma
stage III endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Fulvestrant
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014