Trial Outcomes & Findings for S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery (NCT NCT00770120)

Last Updated: 2020-03-06

Results Overview

Progression-Free Survival was defined as the duration from the date of registration until the date of disease progression per RECIST or death due to any cause. Patients known to be alive without evidence of disease progression were censored at the date of last contact. Disease progression was defined as a \>= 20% increase over nadir in the sum of longest diameters of target lesions, unequivocal progression of non-target lesions in the opinion of the treating investigator, appearance of new lesions, symptomatic deterioration, or death due to disease

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

Every 8 weeks until disease progression, up to 3 years.

Results posted on

2020-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Everolimus Daily oral Everolimus 10 mg/day everolimus
Overall Study STARTED	61
Overall Study Eligible	60
Overall Study Not Analyzable	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	61

Reasons for withdrawal

Reasons for withdrawal
Measure	Everolimus Daily oral Everolimus 10 mg/day everolimus
Overall Study Progression	31
Overall Study Adverse Event	11
Overall Study Not Protocol Specified	11
Overall Study Death	3
Overall Study Withdrawal by Subject	2
Overall Study Ineligible	1
Overall Study Never Received Treatment/Not Analyzable	1
Overall Study Reason under Review	1

Baseline Characteristics

S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Everolimus n=59 Participants Daily oral Everolimus 10 mg/day everolimus
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Histology Epithelial	36 participants n=5 Participants
Histology Mesothelioma, NOS	17 participants n=5 Participants
Histology Biphasic	4 participants n=5 Participants
Histology Not Reported	2 participants n=5 Participants
Number of Metastatic Sites None	5 participants n=5 Participants
Number of Metastatic Sites Single	23 participants n=5 Participants
Number of Metastatic Sites Multiple	31 participants n=5 Participants
Prior Systemic Regimens 1 Regimen	34 participants n=5 Participants
Prior Systemic Regimens 2 Regimens	25 participants n=5 Participants
Performance Status 0	13 participants n=5 Participants
Performance Status 1	46 participants n=5 Participants
Weight Loss Last 6 Months < 5%	47 participants n=5 Participants
Weight Loss Last 6 Months 5% - < 10%	6 participants n=5 Participants
Weight Loss Last 6 Months 10% - 20%	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 8 weeks until disease progression, up to 3 years.

Outcome measures

Outcome measures
Measure	Everolimus n=59 Participants Daily oral Everolimus 10 mg/day everolimus
Progression-Free Survival	3.0 months Interval 1.8 to 3.6

SECONDARY outcome

Timeframe: Every 8 weeks until disease progression, up to 3 years.

A response was defined as either a confirmed or unconfirmed complete or partial responses as defined by RECIST. A complete response (CR) was defined as the disappearance of all disease. A partial response (PR) was defined as a \>= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was considered confirmed if two consecutive determinations were made at least 4 weeks apart.

Outcome measures

Outcome measures
Measure	Everolimus n=45 Participants Daily oral Everolimus 10 mg/day everolimus
Response	2 percentage of overall response rate Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: Every 8 weeks until disease progression, up to 3 years.

Overall survival was defined as the duration between the date of enrollment and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.

Outcome measures

Outcome measures
Measure	Everolimus n=59 Participants Daily oral Everolimus 10 mg/day everolimus
Overall Survival	6.3 months Interval 4.8 to 8.0

SECONDARY outcome

Timeframe: Weekly during the first 8 weeks of treatment, then every 4 weeks while on treatment, then every 8 weeks until disease progression, then every 6 months thereafter.

Population: Number of Subjects With Greater Than Grade 2 Toxicity

Outcome measures

Outcome measures
Measure	Everolimus n=59 Participants Daily oral Everolimus 10 mg/day everolimus
Frequency and Severity of Toxicities Fatigue (asthenia, lethargy, malaise)	6 participants
Frequency and Severity of Toxicities Anorexia	1 participants
Frequency and Severity of Toxicities Confusion	1 participants
Frequency and Severity of Toxicities Dehydration	2 participants
Frequency and Severity of Toxicities Diarrhea	1 participants
Frequency and Severity of Toxicities Dyspnea (shortness of breath)	3 participants
Frequency and Severity of Toxicities Glucose, serum-high (hyperglycemia)	3 participants
Frequency and Severity of Toxicities Hemoglobin	4 participants
Frequency and Severity of Toxicities INR (of prothrombin time)	1 participants
Frequency and Severity of Toxicities Inf (clin/microbio) w/Gr 3-4 neuts - Lung	1 participants
Frequency and Severity of Toxicities Infection with unknown ANC - Lung (pneumonia)	3 participants
Frequency and Severity of Toxicities Left ventricular systolic dysfunction	1 participants
Frequency and Severity of Toxicities Lymphopenia	2 participants
Frequency and Severity of Toxicities Mucositis/stomatitis (clinical exam) - Oral cavity	1 participants
Frequency and Severity of Toxicities Mucositis/stomatitis (functional/symp) - Oral cav	1 participants
Frequency and Severity of Toxicities Muscle weakness, not d/t neuropathy - body/general	2 participants
Frequency and Severity of Toxicities Pneumonitis/pulmonary infiltrates	2 participants
Frequency and Severity of Toxicities Rash/desquamation	1 participants
Frequency and Severity of Toxicities Triglyceride, serum-high (hypertriglyceridemia)	2 participants

Adverse Events

Everolimus

Serious events: 25 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Everolimus n=59 participants at risk Daily oral Everolimus 10 mg/day
Blood and lymphatic system disorders Hemoglobin	5.1% 3/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Cardiac disorders Left ventricular systolic dysfunction	1.7% 1/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Cardiac disorders Pericardial effusion (non-malignant)	1.7% 1/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Diarrhea	3.4% 2/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Hemorrhage, GI - Oral cavity	1.7% 1/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
General disorders Death not associated with CTCAE term - Death NOS	8.5% 5/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Lung	1.7% 1/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Infections and infestations Infection with unknown ANC - Lung (pneumonia)	6.8% 4/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Investigations Neutrophils/granulocytes (ANC/AGC)	1.7% 1/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Metabolism and nutrition disorders Dehydration	1.7% 1/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Musculoskeletal and connective tissue disorders Pain - Back	1.7% 1/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Musculoskeletal and connective tissue disorders Pain - Chest wall	1.7% 1/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death - Disease progression NOS	5.1% 3/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Psychiatric disorders Confusion	1.7% 1/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Aspiration	1.7% 1/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Atelectasis	1.7% 1/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	13.6% 8/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.7% 1/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	3.4% 2/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	6.8% 4/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Vascular disorders Thrombosis/thrombus/embolism	6.8% 4/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.

Other adverse events

Other adverse events
Measure	Everolimus n=59 participants at risk Daily oral Everolimus 10 mg/day
Blood and lymphatic system disorders Hemoglobin	64.4% 38/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Cardiac disorders SVT and nodal arrhythmia - Sinus tachycardia	6.8% 4/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Constipation	22.0% 13/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Diarrhea	23.7% 14/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	5.1% 3/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Dysphagia (difficulty swallowing)	5.1% 3/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Flatulence	5.1% 3/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Gastrointestinal-Other	8.5% 5/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Hemorrhoids	5.1% 3/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	32.2% 19/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Mucositis/stomatitis (functional/symp) - Oral cav	16.9% 10/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Nausea	35.6% 21/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Pain - Abdomen NOS	15.3% 9/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Pain - Oral cavity	5.1% 3/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Gastrointestinal disorders Vomiting	16.9% 10/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
General disorders Constitutional Symptoms-Other	5.1% 3/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
General disorders Edema: limb	13.6% 8/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
General disorders Edema: trunk/genital	5.1% 3/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
General disorders Fatigue (asthenia, lethargy, malaise)	69.5% 41/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
General disorders Fever in absence of neutropenia, ANC lt1.0x10e9/L	6.8% 4/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
General disorders Pain - Chest/thorax NOS	13.6% 8/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
General disorders Pain-Other	6.8% 4/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
General disorders Rigors/chills	6.8% 4/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	8.5% 5/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Investigations AST, SGOT	13.6% 8/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Investigations Alkaline phosphatase	10.2% 6/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Investigations Cholesterol, serum-high (hypercholesterolemia)	32.2% 19/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Investigations Creatinine	23.7% 14/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Investigations Leukocytes (total WBC)	20.3% 12/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Investigations Lymphopenia	15.3% 9/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Investigations Metabolic/Laboratory-Other	5.1% 3/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Investigations Neutrophils/granulocytes (ANC/AGC)	6.8% 4/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Investigations Platelets	27.1% 16/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Investigations Weight loss	27.1% 16/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	25.4% 15/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Metabolism and nutrition disorders Anorexia	45.8% 27/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	13.6% 8/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Metabolism and nutrition disorders Dehydration	10.2% 6/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	44.1% 26/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	8.5% 5/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	8.5% 5/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	13.6% 8/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Metabolism and nutrition disorders Triglyceride, serum-high (hypertriglyceridemia)	50.8% 30/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Musculoskeletal and connective tissue disorders Muscle weakness, not d/t neuropathy - body/general	11.9% 7/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Musculoskeletal and connective tissue disorders Pain - Back	8.5% 5/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Musculoskeletal and connective tissue disorders Pain - Chest wall	16.9% 10/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Nervous system disorders Dizziness	10.2% 6/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Nervous system disorders Neuropathy: sensory	16.9% 10/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Nervous system disorders Pain - Head/headache	6.8% 4/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Nervous system disorders Taste alteration (dysgeusia)	13.6% 8/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Psychiatric disorders Insomnia	10.2% 6/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Psychiatric disorders Mood alteration - anxiety	11.9% 7/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Renal and urinary disorders Urinary frequency/urgency	5.1% 3/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Cough	39.0% 23/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	50.8% 30/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	8.5% 5/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.1% 3/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-Other	5.1% 3/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	6.8% 4/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Skin and subcutaneous tissue disorders Pruritus/itching	8.5% 5/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Skin and subcutaneous tissue disorders Rash/desquamation	18.6% 11/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	8.5% 5/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	6.8% 4/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.
Vascular disorders Hypertension	8.5% 5/59 • From date of registration to 3 years post registration or death (whichever occurs first). All SAEs and AEs.

Additional Information

Lung Committee Statistician

SWOG Statistical Center

Phone: 206-667-6197

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place