Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer
Recruitment status was Active, not recruiting
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Faslodex In Recurrent/Metastatic Endometrial Cancer|
- 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 ]
- Toxicity of fulvestrant by Common Toxicity Criteria [ Designated as safety issue: Yes ]
- Disease-free and overall survival [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
- 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.