Trials / Unknown
UnknownNCT00006903
Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer
Phase II Study of Faslodex ? in Recurrent/Metastatic Endometrial Carcinoma
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Recurrent Uterine Corpus Carcinoma
- Stage III Uterine Corpus Cancer AJCC v7
- Stage IV Uterine Corpus Cancer AJCC v7
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fulvestrant | Given intramuscularly |
Timeline
- Start date
- 2004-08-30
- Primary completion
- 2008-03-17
- First posted
- 2003-01-27
- Last updated
- 2019-03-20
- Results posted
- 2014-06-24
Source: ClinicalTrials.gov record NCT00006903. Inclusion in this directory is not an endorsement.