Trial Outcomes & Findings for Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer (NCT NCT00006903)

NCT ID: NCT00006903

Last Updated: 2019-03-20

Results Overview

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.

• Recruitment status: UNKNOWN
• Study phase: PHASE2
• Target enrollment: 67 participants
• Primary outcome timeframe: Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.
• Results posted on: 2019-03-20

Participant Flow

Participant milestones

Measure	Ineligible Not eligible	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	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
Overall Study STARTED	10	24	33
Overall Study COMPLETED	0	20	27
Overall Study NOT COMPLETED	10	4	6

Reasons for withdrawal

Measure	Ineligible Not eligible	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	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
Overall Study Still receiving treatment	0	0	1
Overall Study Refused further treatment	0	2	1
Overall Study Adverse Event	0	0	1
Overall Study Death	0	1	0
Overall Study Patient never treated	0	0	1
Overall Study Ineligible	10	1	2

Baseline Characteristics

Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer

Baseline characteristics by cohort

Measure	Estrogen Receptor Negative n=23 Participants Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy	Estrogen Receptor Positive n=30 Participants Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy	Total n=53 Participants Total of all reporting groups
Age, Customized	62.9 years STANDARD_DEVIATION 10.2 • n=5 Participants	65.9 years STANDARD_DEVIATION 10.4 • n=7 Participants	64.6 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	30 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.

Population: Total number eligible and treated participants within groups defined by estrogen receptor status in metastatic tumor.

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.

Outcome measures

Measure	Estrogen Receptor Negative n=23 Participants Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy	Estrogen Receptor Positive n=30 Participants Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy	Grade 5 Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks Complete Response	0 participants	1 participants	—
Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks Partial Response	0 participants	4 participants	—
Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks Stable Disease	4 participants	9 participants	—
Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks Disease Progression	18 participants	16 participants	—
Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks Indeterminate	1 participants	0 participants	—

PRIMARY outcome

Timeframe: Every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment, assessed up to 100 months.

Population: Total number eligible and treated participants within groups defined by estrogen receptor status

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

Outcome measures

Measure	Estrogen Receptor Negative n=22 Participants Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy	Estrogen Receptor Positive n=31 Participants Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy	Grade 5 Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Clinical Response by RECIST Criteria of Estrogen Receptor Expression Complete Response	0 Participants	1 Participants	—
Clinical Response by RECIST Criteria of Estrogen Receptor Expression Partial Response	0 Participants	4 Participants	—
Clinical Response by RECIST Criteria of Estrogen Receptor Expression Stable Disease	4 Participants	9 Participants	—
Clinical Response by RECIST Criteria of Estrogen Receptor Expression Increasing Disease	17 Participants	17 Participants	—
Clinical Response by RECIST Criteria of Estrogen Receptor Expression Not Evaluated	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: During study treatment and up to 30 days after stopping study

Population: Eligible and evaluable patients.

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.

Outcome measures

Measure	Estrogen Receptor Negative n=47 Participants Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy	Estrogen Receptor Positive n=47 Participants Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy	Grade 5 n=47 Participants Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
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. Anemia	1 Participants	1 Participants	0 Participants
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. Fatigue	1 Participants	0 Participants	0 Participants
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. Gastrointestinal	1 Participants	0 Participants	0 Participants
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. Nausea	3 Participants	0 Participants	0 Participants
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. Vomiting	1 Participants	0 Participants	0 Participants
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. Diarrhea	1 Participants	0 Participants	0 Participants
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. Anorexia	2 Participants	0 Participants	0 Participants
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. Metabolic	2 Participants	0 Participants	0 Participants
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. Neurologic	2 Participants	0 Participants	0 Participants
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. Depression	1 Participants	0 Participants	0 Participants
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. Pain	1 Participants	0 Participants	0 Participants
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. Dyspnea	1 Participants	0 Participants	0 Participants
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. Thrombosis/embolism, regardless of attribution	0 Participants	3 Participants	1 Participants

Adverse Events

Faslodex

Serious events: 11 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	Faslodex n=53 participants at risk 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.
General disorders Death no ctcae term - disease progression	1.9% 1/53 • 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.
General disorders Death no ctcae term - death nos	1.9% 1/53 • 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.
Gastrointestinal disorders Nausea	3.8% 2/53 • 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.
Gastrointestinal disorders Vomiting	1.9% 1/53 • 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.
Gastrointestinal disorders Constipation	1.9% 1/53 • 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.
Gastrointestinal disorders Distention	1.9% 1/53 • 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.
Gastrointestinal disorders Obstruction, gi - small bowel nos	1.9% 1/53 • 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.
Vascular disorders Hemorrhage, gi - stomach	1.9% 1/53 • 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.
Vascular disorders Hemorrhage/pulmonary - respiratory tract	1.9% 1/53 • 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.
Infections and infestations Infection - other	1.9% 1/53 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.8% 2/53 • 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.
General disorders Pain: abdominal pain nos	1.9% 1/53 • 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.
General disorders Pain: pelvis	1.9% 1/53 • 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.
Vascular disorders Thrombosis/thrombus/embolism	5.7% 3/53 • 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.

Other adverse events

Measure	Faslodex n=53 participants at risk 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.
Blood and lymphatic system disorders Anemia	17.0% 9/53 • 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.
Blood and lymphatic system disorders Neutropenia	1.9% 1/53 • 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.
Ear and labyrinth disorders Auditory	1.9% 1/53 • 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.
General disorders Constitutional	5.7% 3/53 • 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.
General disorders Fatigue	24.5% 13/53 • 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.
Skin and subcutaneous tissue disorders Injection Site Reaction	1.9% 1/53 • 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.
Endocrine disorders Hot Flashes/Flushes	11.3% 6/53 • 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.
Gastrointestinal disorders Gastrointestinal	11.3% 6/53 • 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.
Gastrointestinal disorders Nausea	11.3% 6/53 • 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.
Gastrointestinal disorders Vomiting	5.7% 3/53 • 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.
Gastrointestinal disorders Diarrhea	1.9% 1/53 • 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.
Gastrointestinal disorders Anorexia	15.1% 8/53 • 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.
Infections and infestations Infection/Fever	1.9% 1/53 • 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.
Metabolism and nutrition disorders Metabolic	7.5% 4/53 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal	1.9% 1/53 • 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.
Nervous system disorders Neurologic	5.7% 3/53 • 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.
Nervous system disorders Depression	11.3% 6/53 • 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.
Eye disorders Ocular/Visual	1.9% 1/53 • 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.
General disorders Pain	15.1% 8/53 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.5% 4/53 • 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.
Vascular disorders Thrombosis/embolism	7.5% 4/53 • 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.

Additional Information

Melissa Leventhal

NRG Oncology, Statistics and Data Management Center, Buffalo Office

Phone: 716-845-4030

Email: mleventhal@gogstats.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place