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Trial record 16 of 360 for:    "Malignant mesothelioma"

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

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ClinicalTrials.gov Identifier: NCT00770120
Recruitment Status : Completed
First Posted : October 9, 2008
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Mesothelioma
Intervention Drug: everolimus
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Everolimus
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Daily oral Everolimus 10 mg/day

everolimus

Period Title: Overall Study
Started 61
Eligible 60
Not Analyzable 1
Completed 0
Not Completed 61
Reason Not Completed
Progression             31
Adverse Event             11
Not Protocol Specified             11
Death             3
Withdrawal by Subject             2
Ineligible             1
Never Received Treatment/Not Analyzable             1
Reason under Review             1
Arm/Group Title Everolimus
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Daily oral Everolimus 10 mg/day

everolimus

Overall Number of Baseline Participants 59
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Number of patients who were eligible and received treatment and thus analyzable.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 59 participants
67
(45.8 to 81.3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
14
  23.7%
Male
45
  76.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Hispanic or Latino
9
  15.3%
Not Hispanic or Latino
47
  79.7%
Unknown or Not Reported
3
   5.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.7%
White
55
  93.2%
More than one race
0
   0.0%
Unknown or Not Reported
3
   5.1%
Histology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants
Epithelial 36
Mesothelioma, NOS 17
Biphasic 4
Not Reported 2
Number of Metastatic Sites  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants
None 5
Single 23
Multiple 31
Prior Systemic Regimens  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants
1 Regimen 34
2 Regimens 25
Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants
0 13
1 46
[1]
Measure Description:

0: Fully active, able to carry on all pre-disease performance without restriction.

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.
  2. Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
  3. Capable of limited self-care, confined to bed or chair more than 50% of waking hours.
  4. Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
Weight Loss Last 6 Months  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants
< 5% 47
5% - < 10% 6
10% - 20% 6
1.Primary Outcome
Title Progression-Free Survival
Hide Description 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
Time Frame Every 8 weeks until disease progression, up to 3 years.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Everolimus
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Daily oral Everolimus 10 mg/day

everolimus

Overall Number of Participants Analyzed 59
Median (95% Confidence Interval)
Unit of Measure: months
3.0
(1.8 to 3.6)
2.Secondary Outcome
Title Response
Hide Description 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.
Time Frame Every 8 weeks until disease progression, up to 3 years.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Everolimus
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Daily oral Everolimus 10 mg/day

everolimus

Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of overall response rate
2
(0 to 12)
3.Secondary Outcome
Title Overall Survival
Hide Description 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.
Time Frame Every 8 weeks until disease progression, up to 3 years.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Everolimus
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Daily oral Everolimus 10 mg/day

everolimus

Overall Number of Participants Analyzed 59
Median (95% Confidence Interval)
Unit of Measure: months
6.3
(4.8 to 8)
4.Secondary Outcome
Title Frequency and Severity of Toxicities
Hide Description [Not Specified]
Time Frame 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.
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Hide Analysis Population Description
Number of Subjects With Greater Than Grade 2 Toxicity
Arm/Group Title Everolimus
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Daily oral Everolimus 10 mg/day
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: participants
Anorexia 1
Confusion 1
Dehydration 2
Diarrhea 1
Dyspnea (shortness of breath) 3
Fatigue (asthenia, lethargy, malaise) 6
Glucose, serum-high (hyperglycemia) 3
Hemoglobin 4
INR (of prothrombin time) 1
Inf (clin/microbio) w/Gr 3-4 neuts - Lung 1
Infection with unknown ANC - Lung (pneumonia) 3
Left ventricular systolic dysfunction 1
Lymphopenia 2
Mucositis/stomatitis (clinical exam) - Oral cavity 1
Mucositis/stomatitis (functional/symp) - Oral cav 1
Muscle weakness, not d/t neuropathy - body/general 2
Pneumonitis/pulmonary infiltrates 2
Rash/desquamation 1
Triglyceride, serum-high (hypertriglyceridemia) 2
Time Frame From date of registration to 3 years post registration or death (whichever occurs first).
Adverse Event Reporting Description All SAEs and AEs.
 
Arm/Group Title Everolimus
Hide Arm/Group Description Daily oral Everolimus 10 mg/day
All-Cause Mortality
Everolimus
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Everolimus
Affected / at Risk (%)
Total   25/59 (42.37%) 
Blood and lymphatic system disorders   
Hemoglobin  1  3/59 (5.08%) 
Cardiac disorders   
Left ventricular systolic dysfunction  1  1/59 (1.69%) 
Pericardial effusion (non-malignant)  1  1/59 (1.69%) 
Gastrointestinal disorders   
Diarrhea  1  2/59 (3.39%) 
Hemorrhage, GI - Oral cavity  1  1/59 (1.69%) 
General disorders   
Death not associated with CTCAE term - Death NOS  1  5/59 (8.47%) 
Infections and infestations   
Inf w/normal ANC or Gr 1-2 neutrophils - Lung  1  1/59 (1.69%) 
Infection with unknown ANC - Lung (pneumonia)  1  4/59 (6.78%) 
Investigations   
Neutrophils/granulocytes (ANC/AGC)  1  1/59 (1.69%) 
Metabolism and nutrition disorders   
Dehydration  1  1/59 (1.69%) 
Musculoskeletal and connective tissue disorders   
Pain - Back  1  1/59 (1.69%) 
Pain - Chest wall  1  1/59 (1.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death - Disease progression NOS  1  3/59 (5.08%) 
Psychiatric disorders   
Confusion  1  1/59 (1.69%) 
Respiratory, thoracic and mediastinal disorders   
Aspiration  1  1/59 (1.69%) 
Atelectasis  1  1/59 (1.69%) 
Dyspnea (shortness of breath)  1  8/59 (13.56%) 
Hypoxia  1  1/59 (1.69%) 
Pleural effusion (non-malignant)  1  2/59 (3.39%) 
Pneumonitis/pulmonary infiltrates  1  4/59 (6.78%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1  4/59 (6.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Everolimus
Affected / at Risk (%)
Total   58/59 (98.31%) 
Blood and lymphatic system disorders   
Hemoglobin  1  38/59 (64.41%) 
Cardiac disorders   
SVT and nodal arrhythmia - Sinus tachycardia  1  4/59 (6.78%) 
Gastrointestinal disorders   
Constipation  1  13/59 (22.03%) 
Diarrhea  1  14/59 (23.73%) 
Dry mouth/salivary gland (xerostomia)  1  3/59 (5.08%) 
Dysphagia (difficulty swallowing)  1  3/59 (5.08%) 
Flatulence  1  3/59 (5.08%) 
Gastrointestinal-Other  1  5/59 (8.47%) 
Hemorrhoids  1  3/59 (5.08%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  19/59 (32.20%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  10/59 (16.95%) 
Nausea  1  21/59 (35.59%) 
Pain - Abdomen NOS  1  9/59 (15.25%) 
Pain - Oral cavity  1  3/59 (5.08%) 
Vomiting  1  10/59 (16.95%) 
General disorders   
Constitutional Symptoms-Other  1  3/59 (5.08%) 
Edema: limb  1  8/59 (13.56%) 
Edema: trunk/genital  1  3/59 (5.08%) 
Fatigue (asthenia, lethargy, malaise)  1  41/59 (69.49%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  4/59 (6.78%) 
Pain - Chest/thorax NOS  1  8/59 (13.56%) 
Pain-Other  1  4/59 (6.78%) 
Rigors/chills  1  4/59 (6.78%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  5/59 (8.47%) 
AST, SGOT  1  8/59 (13.56%) 
Alkaline phosphatase  1  6/59 (10.17%) 
Cholesterol, serum-high (hypercholesterolemia)  1  19/59 (32.20%) 
Creatinine  1  14/59 (23.73%) 
Leukocytes (total WBC)  1  12/59 (20.34%) 
Lymphopenia  1  9/59 (15.25%) 
Metabolic/Laboratory-Other  1  3/59 (5.08%) 
Neutrophils/granulocytes (ANC/AGC)  1  4/59 (6.78%) 
Platelets  1  16/59 (27.12%) 
Weight loss  1  16/59 (27.12%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  15/59 (25.42%) 
Anorexia  1  27/59 (45.76%) 
Calcium, serum-low (hypocalcemia)  1  8/59 (13.56%) 
Dehydration  1  6/59 (10.17%) 
Glucose, serum-high (hyperglycemia)  1  26/59 (44.07%) 
Potassium, serum-high (hyperkalemia)  1  5/59 (8.47%) 
Potassium, serum-low (hypokalemia)  1  5/59 (8.47%) 
Sodium, serum-low (hyponatremia)  1  8/59 (13.56%) 
Triglyceride, serum-high (hypertriglyceridemia)  1  30/59 (50.85%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness, not d/t neuropathy - body/general  1  7/59 (11.86%) 
Pain - Back  1  5/59 (8.47%) 
Pain - Chest wall  1  10/59 (16.95%) 
Nervous system disorders   
Dizziness  1  6/59 (10.17%) 
Neuropathy: sensory  1  10/59 (16.95%) 
Pain - Head/headache  1  4/59 (6.78%) 
Taste alteration (dysgeusia)  1  8/59 (13.56%) 
Psychiatric disorders   
Insomnia  1  6/59 (10.17%) 
Mood alteration - anxiety  1  7/59 (11.86%) 
Renal and urinary disorders   
Urinary frequency/urgency  1  3/59 (5.08%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  23/59 (38.98%) 
Dyspnea (shortness of breath)  1  30/59 (50.85%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  5/59 (8.47%) 
Hypoxia  1  3/59 (5.08%) 
Pulmonary/Upper Respiratory-Other  1  3/59 (5.08%) 
Voice changes/dysarthria  1  4/59 (6.78%) 
Skin and subcutaneous tissue disorders   
Pruritus/itching  1  5/59 (8.47%) 
Rash/desquamation  1  11/59 (18.64%) 
Rash: acne/acneiform  1  5/59 (8.47%) 
Sweating (diaphoresis)  1  4/59 (6.78%) 
Vascular disorders   
Hypertension  1  5/59 (8.47%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lung Committee Statistician
Organization: SWOG Statistical Center
Phone: 206-667-6197
Publications of Results:
Garland LL, Ou SH, Moon J, et al.: SWOG 0722: A phase II study of mTOR inhibitor everolimus (RAD001) in malignant pleural mesothelioma (MPM). [Abstract] J Clin Oncol 30 (Suppl 15): A-7083, 2012.
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00770120     History of Changes
Other Study ID Numbers: CDR0000616162
S0722 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: October 8, 2008
First Posted: October 9, 2008
Results First Submitted: October 26, 2016
Results First Posted: March 1, 2017
Last Update Posted: March 1, 2017