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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00581 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000068339 | |||
| GOG-0188 | Other Identifier | NRG Oncology | |
| GOG-0188 | Other Identifier | CTEP | |
| U10CA180868 | U.S. NIH Grant/Contract | View source | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (fulvestrant) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | Given intramuscularly |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment. |
| 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 | Every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment, assessed up to 100 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
Measurable disease:
Performance status:
Hematopoietic:
Hepatic:
Renal:
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
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| Name | Affiliation | Role |
|---|---|---|
| Allan L Covens | NRG Oncology | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ineligible | Not eligible |
| FG001 | Estrogen Receptor Negative | Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy |
| FG002 | Estrogen Receptor Positive | Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Total number of eligible and treated participants by estrogen receptor status in metastatic tumor
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| ID | Title | Description |
|---|---|---|
| BG000 | Estrogen Receptor Negative | Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy |
| BG001 | Estrogen Receptor Positive |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Total number eligible and treated participants within groups defined by estrogen receptor status in metastatic tumor. | Posted | Number | participants | Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment. |
Study treatment, and up to 30 days after stopping study treatment.
The frequencies of maximum grade of serious adverse event or, for other adverse events, treatment-related adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Other Adverse Events reported are Grade 2 or higher.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Faslodex | Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy. Includes both Estrogen Receptor Positive and Estrogen Receptor Negative participants. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death no ctcae term - disease progression | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
Accrual was discontinued after completion of the first stage of accrual due to lack of study drug activity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Leventhal | NRG Oncology, Statistics and Data Management Center, Buffalo Office | 716-845-4030 | mleventhal@gogstats.org |
| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
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| During study treatment and up to 30 days after stopping study |
| Adverse Event |
|
| Death |
|
| Patient never treated |
|
| Ineligible |
|
Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | 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 | Total number eligible and treated participants within groups defined by estrogen receptor status | Posted | Count of Participants | Participants | Every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment, assessed up to 100 months. |
|
|
|
| Secondary | 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. | Eligible and evaluable patients. | Posted | Count of Participants | Participants | During study treatment and up to 30 days after stopping study |
|
|
|
| 11 |
| 53 |
| 28 |
| 53 |
| Death no ctcae term - death nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Distention | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Obstruction, gi - small bowel nos | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hemorrhage, gi - stomach | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hemorrhage/pulmonary - respiratory tract | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection - other | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pain: abdominal pain nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pain: pelvis | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Auditory | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Constitutional | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Injection Site Reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hot Flashes/Flushes | Endocrine disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection/Fever | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Metabolic | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neurologic | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Depression | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Ocular/Visual | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Thrombosis/embolism | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Stable Disease |
|
| Increasing Disease |
|
| Not Evaluated |
|
| Title | Measurements |
|---|---|
|
| Gastrointestinal |
|
| Nausea |
|
| Vomiting |
|
| Diarrhea |
|
| Anorexia |
|
| Metabolic |
|
| Neurologic |
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| Depression |
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| Pain |
|
| Dyspnea |
|
| Thrombosis/embolism, regardless of attribution |
|