Back to resultsFulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer
Primary Purpose
Recurrent Uterine Corpus Carcinoma, Stage III Uterine Corpus Cancer AJCC v7, Stage IV Uterine Corpus Cancer AJCC v7
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fulvestrant
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Uterine Corpus Carcinoma
Eligibility Criteria
Criteria: 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 Performance status: GOG 0-1 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 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 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 At least 3 weeks since prior hormonal therapy and recovered At least 3 weeks since prior radiotherapy and recovered At least 3 weeks since prior surgery and recovered
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (fulvestrant)
Arm Description
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.
Outcomes
Primary Outcome Measures
Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks
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
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 Outcome Measures
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.
Adverse events at least possibly related to Fulvestrant using Common Terminology Criteria version 3.0 that were grade 3 or higher with the exception of the reported Grade 5. Grade 5 adverse events were reported regardless of attribution to study treatment.
Full Information
NCT ID
NCT00006903
First Posted
December 6, 2000
Last Updated
March 8, 2019
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00006903
Brief Title
Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer
Official Title
Phase II Study of Faslodex ? in Recurrent/Metastatic Endometrial Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2004 (Actual)
Primary Completion Date
March 17, 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Uterine Corpus Carcinoma, Stage III Uterine Corpus Cancer AJCC v7, Stage IV Uterine Corpus Cancer AJCC v7
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (fulvestrant)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Fulvestrant
Other Intervention Name(s)
Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780, ZD9238
Intervention Description
Given intramuscularly
Primary Outcome Measure Information:
Title
Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks
Description
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.
Time Frame
Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.
Title
Clinical Response by RECIST Criteria of Estrogen Receptor Expression
Description
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
Time Frame
Every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment, assessed up to 100 months.
Secondary Outcome Measure Information:
Title
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.
Description
Adverse events at least possibly related to Fulvestrant using Common Terminology Criteria version 3.0 that were grade 3 or higher with the exception of the reported Grade 5. Grade 5 adverse events were reported regardless of attribution to study treatment.
Time Frame
During study treatment and up to 30 days after stopping study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria:
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
Performance status:
GOG 0-1
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
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
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
At least 3 weeks since prior hormonal therapy and recovered
At least 3 weeks since prior radiotherapy and recovered
At least 3 weeks since prior surgery and recovered
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan L Covens
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer
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