Phase II Study of Faslodex ? in Recurrent/Metastatic Endometrial Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Fulvestrant
- Conditions
- Recurrent Uterine Corpus Carcinoma
- Sponsor
- Gynecologic Oncology Group
- Enrollment
- 67
- Primary Endpoint
- Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (fulvestrant)
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.
Intervention: Fulvestrant
Outcomes
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.
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, assessed up to 100 months.
Per response evaluation criteria in Solid Tumors Criteria (RECIST 1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \>=30% decrease in the sum of the longest diameter of target lesions. Overall Response = CR+PR
Secondary Outcomes
- 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.(During study treatment and up to 30 days after stopping study)