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S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00243074
Recruitment Status : Completed
First Posted : October 21, 2005
Results First Posted : October 21, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced Malignant Mesothelioma
Epithelial Mesothelioma
Recurrent Malignant Mesothelioma
Sarcomatous Mesothelioma
Interventions Drug: cediranib maleate
Other: laboratory biomarker analysis
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AZD2171 (Cediranib Maleate)
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 54
Completed 0
Not Completed 54
Reason Not Completed
Ineligible             6
Adverse Event             6
Withdrawal by Subject             2
Lack of Efficacy             36
Death             2
not protocol specified             1
Did not receive any treatment             1
Arm/Group Title AZD2171
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
Only eligible patients who received protocol treatment are included in the analysis. Of the 54 patients enrolled, 6 were ineligible and 1 addtional patients refused protocol treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 47 participants
66
(43 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
9
  19.1%
Male
38
  80.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Hispanic or Latino
2
   4.3%
Not Hispanic or Latino
41
  87.2%
Unknown or Not Reported
4
   8.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 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
0
   0.0%
White
44
  93.6%
More than one race
0
   0.0%
Unknown or Not Reported
3
   6.4%
1.Primary Outcome
Title Overall Response Rate
Hide Description confirmed complete and partial responses per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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 (OR) = CR + PR.".
Time Frame Disease assessments for response were performed every 8 weeks for as long as the patient remained on protocol treatment, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any amount of AZD2171
Arm/Group Title AZD2171 (Cediranib Maleate)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9
(2 to 20)
2.Secondary Outcome
Title Overall Survival
Hide Description From the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
Time Frame Daily during protocol treatment; then every 8 weeks until progression; then every 6 months for up to 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received AZD2171
Arm/Group Title AZD2171
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: months
9.5
(5.6 to 10.7)
3.Secondary Outcome
Title Progression-free Survival
Hide Description From the date of enrollment until the date of disease progression (as determined by standard RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame Every 8 weeks until disease progression or death, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received AZD2171
Arm/Group Title AZD2171
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: months
2.6
(1.7 to 3.7)
4.Secondary Outcome
Title Disease Control Rate
Hide Description The percentage of patients with a best of response of stable disease or better per standard RECIST. That is, patients whose best response was not increasing disease or death.
Time Frame Every 8 weeks until disease progression progression, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received AZD2171
Arm/Group Title AZD2171
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44
(28 to 58)
5.Secondary Outcome
Title Objective Response Rate Per Modified RECIST for Pleural Tumors
Hide Description The sum of 6 pleural thickness measurements is added to sum of the longest diameters of all non-pleural measurable lesions. The resulting values are evaluated using RECIST.
Time Frame Disease assessments for response were performed every 8 weeks as long as the patient remained on protocol treatment, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any amount of AZD2171
Arm/Group Title AZD2171
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2
(0 to 11)
6.Secondary Outcome
Title Adverse Event Rates
Hide Description Adverse events per the NCI Common Toxicity Criteria version 3.0 that were possibly, probably or definitely related to protocol treatment. See adverse event tables for specific details.
Time Frame Daily during protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received protocol treatment were assessed for adverse events. See adverse event tables for specific details.
Arm/Group Title AZD2171 (Cediranib Maleate)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Measure Type: Count of Participants
Unit of Measure: Participants
47
 100.0%
7.Secondary Outcome
Title Adverse Events
Hide Description Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Patients were assessed for adverse events every day for as long as they remained on protocol treatment, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any amount of protocol treatment with AZD2171 (cediranib maleate)
Arm/Group Title AZD2171 (Cediranib Maleate)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: Participants
Anorexia 3
Apnea 1
Ataxia (incoordination) 1
Cognitive disturbance 1
Colitis 1
Confusion 2
Constipation 1
Dehydration 3
Diarrhea 4
Dizziness 1
Encephalopathy 1
Fatigue (asthenia, lethargy, malaise) 7
Hypertension 15
Hypotension 1
Inf (clin/microbio) w/Gr 3-4 neuts - Blood 1
Memory impairment 1
Metabolic/Laboratory-Other (Specify) 1
Muscle weakness, not d/t neuropathy - body/general 1
Nausea 2
Necrosis, GI - Esophagus 1
Neuropathy: sensory 1
Pain - Chest wall 1
Pain - Head/headache 1
Pain - Intestine 1
Pain - Pain NOS 1
Pain - Tumor pain 1
Perforation, GI - Ileum 1
Potassium, serum-low (hypokalemia) 1
Proteinuria 2
Rash: hand-foot skin reaction 2
Renal failure 2
Sodium, serum-low (hyponatremia) 1
Speech impairment (e.g., dysphasia or aphasia) 1
Thrombosis/thrombus/embolism 3
Vomiting 1
Weight loss 2
Time Frame Daily during protocol treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD2171
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
AZD2171
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
AZD2171
Affected / at Risk (%)
Total   22/47 (46.81%) 
Endocrine disorders   
Thyroid function, low (hypothyroidism) † 1  1/47 (2.13%) 
Gastrointestinal disorders   
Constipation † 1  1/47 (2.13%) 
Gastrointestinal-Other (Specify) † 1  1/47 (2.13%) 
Necrosis, GI - Esophagus † 1  1/47 (2.13%) 
Obstruction, GI - Small bowel NOS † 1  1/47 (2.13%) 
Pain - Peritoneum † 1  1/47 (2.13%) 
Perforation, GI - Colon † 1  1/47 (2.13%) 
General disorders   
Death not associated with CTCAE term - Death NOS † 1  1/47 (2.13%) 
Fatigue (asthenia, lethargy, malaise) † 1  1/47 (2.13%) 
Sudden death † 1  1/47 (2.13%) 
Infections and infestations   
Inf (clin/microbio) w/Gr 3-4 neuts - Blood † 1  1/47 (2.13%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Blood † 1  1/47 (2.13%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung † 1  3/47 (6.38%) 
Infection-Other (Specify) † 1  1/47 (2.13%) 
Metabolism and nutrition disorders   
Anorexia † 1  1/47 (2.13%) 
Dehydration † 1  3/47 (6.38%) 
Sodium, serum-low (hyponatremia) † 1  1/47 (2.13%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness, not d/t neuropathy - body/general † 1  1/47 (2.13%) 
Pain - Chest wall † 1  1/47 (2.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death - Disease progression NOS † 1  8/47 (17.02%) 
Nervous system disorders   
Ataxia (incoordination) † 1  1/47 (2.13%) 
Cognitive disturbance † 1  1/47 (2.13%) 
Encephalopathy † 1  1/47 (2.13%) 
Memory impairment † 1  1/47 (2.13%) 
Psychiatric disorders   
Confusion † 1  2/47 (4.26%) 
Renal and urinary disorders   
Hemorrhage, GU - Urethra † 1  1/47 (2.13%) 
Renal failure † 1  2/47 (4.26%) 
Respiratory, thoracic and mediastinal disorders   
Apnea † 1  1/47 (2.13%) 
Hypoxia † 1  1/47 (2.13%) 
Pain - Throat/pharynx/larynx † 1  1/47 (2.13%) 
Vascular disorders   
Hypertension † 1  1/47 (2.13%) 
Hypotension † 1  1/47 (2.13%) 
Thrombosis/thrombus/embolism † 1  2/47 (4.26%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD2171
Affected / at Risk (%)
Total   42/47 (89.36%) 
Blood and lymphatic system disorders   
Hemoglobin † 1  13/47 (27.66%) 
Endocrine disorders   
Thyroid function, low (hypothyroidism) † 1  5/47 (10.64%) 
Gastrointestinal disorders   
Constipation † 1  10/47 (21.28%) 
Diarrhea † 1  30/47 (63.83%) 
Distention/bloating, abdominal † 1  5/47 (10.64%) 
Dry mouth/salivary gland (xerostomia) † 1  5/47 (10.64%) 
Dysphagia (difficulty swallowing) † 1  5/47 (10.64%) 
Gastrointestinal-Other (Specify) † 1  7/47 (14.89%) 
Heartburn/dyspepsia † 1  5/47 (10.64%) 
Hemorrhage, GI - Rectum † 1  3/47 (6.38%) 
Mucositis/stomatitis (clinical exam) - Oral cavity † 1  3/47 (6.38%) 
Mucositis/stomatitis (functional/symp) - Oral cav † 1  4/47 (8.51%) 
Nausea † 1  17/47 (36.17%) 
Pain - Abdomen NOS † 1  7/47 (14.89%) 
Vomiting † 1  10/47 (21.28%) 
General disorders   
Constitutional Symptoms-Other (Specify) † 1  3/47 (6.38%) 
Edema: limb † 1  5/47 (10.64%) 
Fatigue (asthenia, lethargy, malaise) † 1  35/47 (74.47%) 
Pain - Chest/thorax NOS † 1  6/47 (12.77%) 
Injury, poisoning and procedural complications   
Bruising (in absence of Gr 3-4 thrombocytopenia) † 1  3/47 (6.38%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase) † 1  8/47 (17.02%) 
AST, SGOT † 1  8/47 (17.02%) 
Alkaline phosphatase † 1  7/47 (14.89%) 
Creatinine † 1  9/47 (19.15%) 
Leukocytes (total WBC) † 1  3/47 (6.38%) 
Lymphopenia † 1  3/47 (6.38%) 
Metabolic/Laboratory-Other (Specify) † 1  9/47 (19.15%) 
Platelets † 1  7/47 (14.89%) 
Weight loss † 1  17/47 (36.17%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia) † 1  9/47 (19.15%) 
Anorexia † 1  20/47 (42.55%) 
Calcium, serum-low (hypocalcemia) † 1  5/47 (10.64%) 
Dehydration † 1  7/47 (14.89%) 
Glucose, serum-high (hyperglycemia) † 1  18/47 (38.30%) 
Potassium, serum-high (hyperkalemia) † 1  5/47 (10.64%) 
Potassium, serum-low (hypokalemia) † 1  4/47 (8.51%) 
Sodium, serum-low (hyponatremia) † 1  7/47 (14.89%) 
Musculoskeletal and connective tissue disorders   
Pain - Chest wall † 1  4/47 (8.51%) 
Pain - Extremity-limb † 1  4/47 (8.51%) 
Pain - Joint † 1  3/47 (6.38%) 
Pain - Muscle † 1  6/47 (12.77%) 
Pain - Neck † 1  3/47 (6.38%) 
Nervous system disorders   
Neuropathy: sensory † 1  5/47 (10.64%) 
Pain - Head/headache † 1  9/47 (19.15%) 
Psychiatric disorders   
Insomnia † 1  3/47 (6.38%) 
Mood alteration - anxiety † 1  4/47 (8.51%) 
Mood alteration - depression † 1  3/47 (6.38%) 
Renal and urinary disorders   
Proteinuria † 1  14/47 (29.79%) 
Renal/Genitourinary-Other (Specify) † 1  5/47 (10.64%) 
Urinary frequency/urgency † 1  3/47 (6.38%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1  14/47 (29.79%) 
Dyspnea (shortness of breath) † 1  18/47 (38.30%) 
Pulmonary/Upper Respiratory-Other (Specify) † 1  3/47 (6.38%) 
Voice changes/dysarthria † 1  17/47 (36.17%) 
Skin and subcutaneous tissue disorders   
Rash/desquamation † 1  4/47 (8.51%) 
Rash: hand-foot skin reaction † 1  3/47 (6.38%) 
Sweating (diaphoresis) † 1  4/47 (8.51%) 
Vascular disorders   
Hypertension † 1  34/47 (72.34%) 
Thrombosis/thrombus/embolism † 1  3/47 (6.38%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Lung Committee Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
EMail: jmoon@fredhutch.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00243074    
Other Study ID Numbers: NCI-2012-02902
S0509
U10CA032102 ( U.S. NIH Grant/Contract )
CDR0000446178 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: October 20, 2005
First Posted: October 21, 2005
Results First Submitted: October 30, 2012
Results First Posted: October 21, 2015
Last Update Posted: January 23, 2018