This trial is active, not recruiting.

Condition endometrial cancer
Treatment fulvestrant
Phase phase 2
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date August 2004
End date November 2010
Trial size 67 participants
Trial identifier NCT00006903, CDR0000068339, GOG-0188


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

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.
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 Outcomes

Toxicity of Fulvestrant by Common Toxicity Criteria
time frame: During study treatment and up to 30 days after stopping study

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Phase II Study of Faslodex In Recurrent/Metastatic Endometrial Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Gynecologic Oncology Group.