Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer
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:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Faslodex In Recurrent/Metastatic Endometrial Cancer|
- 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 ]
- 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 ]
|Study Start Date:||August 2004|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Fulvestrant IM 250mg per month
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006903
Show 52 Study Locations
|Study Chair:||Allan Covens, MD||Toronto Sunnybrook Regional Cancer Centre|