Clinical trial NCT00006903: Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer
Official title: Phase II Study of Faslodex ? in Recurrent/Metastatic Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Uterine Corpus Carcinoma
Stage III Uterine Corpus Cancer AJCC v7
Stage IV Uterine Corpus Cancer AJCC v7
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks
timeFrame: Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.
measure: Clinical Response by RECIST Criteria of Estrogen Receptor Expression
timeFrame: Every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment, assessed up to 100 months.
Secondary outcomes:
measure: Number of Participants With Grade 3 or Greater Toxicity by Common Toxicity Criteria Version 3.0 That Were at Least Possibly Related to Study Drug.
timeFrame: During study treatment and up to 30 days after stopping study
Other outcomes:
Locations:
Study officials:
affiliation: NRG Oncology
name: Allan L Covens
role: PRINCIPAL_INVESTIGATOR
References: