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Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy

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ClinicalTrials.gov Identifier: NCT01085630
Recruitment Status : Active, not recruiting
First Posted : March 12, 2010
Results First Posted : March 5, 2019
Last Update Posted : August 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Mesothelioma
Interventions Drug: pemetrexed disodium
Other: clinical observation
Enrollment 72
Recruitment Details  
Pre-assignment Details 19 enrolled patients were not randomized for the following reasons: progression during first-line therapy, patient refusal, new disease grade 4 brain tumor, patient expired prior to randomization, insufficient creatinine levels, > 1 week needed to randomize, prolonged adverse events, ineligible due to ECOG performance status being 2 or 3.
Arm/Group Title Arm A (Observation) Arm B (Pemetrexed)
Hide Arm/Group Description Patients undergo observation until disease progression. Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
Period Title: Overall Study
Started 26 27
Completed 22 27
Not Completed 4 0
Reason Not Completed
Insufficient data             1             0
Ineligible             3             0
Arm/Group Title Arm A (Observation) Arm B (Pemetrexed) Total
Hide Arm/Group Description Patients undergo observation until disease progression. Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity. Total of all reporting groups
Overall Number of Baseline Participants 22 27 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 27 participants 49 participants
68.1  (10.2) 71.0  (9.0) 69.7  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 27 participants 49 participants
Female
7
  31.8%
6
  22.2%
13
  26.5%
Male
15
  68.2%
21
  77.8%
36
  73.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 27 participants 49 participants
Unknown
1
   4.5%
3
  11.1%
4
   8.2%
White
21
  95.5%
23
  85.2%
44
  89.8%
Black/African American
0
   0.0%
1
   3.7%
1
   2.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants 27 participants 49 participants
22
 100.0%
27
 100.0%
49
 100.0%
ECOG Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 27 participants 49 participants
0
6
  27.3%
9
  33.3%
15
  30.6%
1
16
  72.7%
18
  66.7%
34
  69.4%
[1]
Measure Description: Eastern Cooperative Oncology Group PS Scale: 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 house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
1.Primary Outcome
Title Progression-free Survival
Hide Description Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time Frame Baseline up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Observation) Arm B (Pemetrexed)
Hide Arm/Group Description:
Patients undergo observation until disease progression.
Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
Overall Number of Participants Analyzed 22 27
Median (95% Confidence Interval)
Unit of Measure: months
3.0
(2.6 to 11.9)
3.4
(2.8 to 9.8)
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time Frame Baseline up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Observation) Arm B (Pemetrexed)
Hide Arm/Group Description:
Patients undergo observation until disease progression.
Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
Overall Number of Participants Analyzed 22 27
Median (95% Confidence Interval)
Unit of Measure: months
11.8
(9.3 to 28.7)
16.3
(10.5 to 26.0)
3.Secondary Outcome
Title Response Rate
Hide Description The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient on the observation arm did not submit any follow-up forms and withdrew consent to all follow-up and thus excluded in this analysis.
Arm/Group Title Arm A (Observation) Arm B (Pemetrexed)
Hide Arm/Group Description:
Patients undergo observation until disease progression.
Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
Overall Number of Participants Analyzed 21 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
11.1
(2.4 to 29.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Observation), Arm B (Pemetrexed)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2423
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)
Hide Description The number of patients reporting grade 3 or higher adverse events considered at least possibly related to study treatment as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.
Time Frame Baseline up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm B (Pemetrexed)
Hide Arm/Group Description:
Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 3 Adverse Event
9
  33.3%
Grade 4 Adverse Event
2
   7.4%
Time Frame Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years.
Adverse Event Reporting Description Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
 
Arm/Group Title Arm B (Pemetrexed)
Hide Arm/Group Description Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
All-Cause Mortality
Arm B (Pemetrexed)
Affected / at Risk (%)
Total   0/27 (0.00%)    
Hide Serious Adverse Events
Arm B (Pemetrexed)
Affected / at Risk (%) # Events
Total   3/27 (11.11%)    
Blood and lymphatic system disorders   
Anemia  1  1/27 (3.70%)  1
Ear and labyrinth disorders   
Hearing impaired  1  1/27 (3.70%)  2
Gastrointestinal disorders   
Abdominal distension  1  1/27 (3.70%)  1
Abdominal pain  1  1/27 (3.70%)  1
Ascites  1  1/27 (3.70%)  1
Ileus  1  1/27 (3.70%)  1
Nausea  1  1/27 (3.70%)  1
General disorders   
Fatigue  1  1/27 (3.70%)  2
Infections and infestations   
Skin infection  1  1/27 (3.70%)  1
Urinary tract infection  1  1/27 (3.70%)  1
Investigations   
Alanine aminotransferase increased  1  1/27 (3.70%)  1
Aspartate aminotransferase increased  1  1/27 (3.70%)  1
Creatinine increased  1  2/27 (7.41%)  2
INR increased  1  1/27 (3.70%)  1
Platelet count decreased  1  1/27 (3.70%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1  1/27 (3.70%)  2
Hypoalbuminemia  1  2/27 (7.41%)  2
Hypocalcemia  1  1/27 (3.70%)  1
Hypokalemia  1  1/27 (3.70%)  1
Nervous system disorders   
Peripheral sensory neuropathy  1  1/27 (3.70%)  2
Psychiatric disorders   
Anxiety  1  1/27 (3.70%)  2
Renal and urinary disorders   
Proteinuria  1  2/27 (7.41%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/27 (7.41%)  2
Pleural effusion  1  1/27 (3.70%)  1
Vascular disorders   
Thromboembolic event  1  1/27 (3.70%)  2
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm B (Pemetrexed)
Affected / at Risk (%) # Events
Total   27/27 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  18/27 (66.67%)  101
Febrile neutropenia  1  1/27 (3.70%)  1
Cardiac disorders   
Atrial fibrillation  1  1/27 (3.70%)  1
Palpitations  1  1/27 (3.70%)  1
Sinus tachycardia  1  1/27 (3.70%)  1
Ear and labyrinth disorders   
Hearing impaired  1  1/27 (3.70%)  3
Vertigo  1  1/27 (3.70%)  1
Eye disorders   
Dry eye  1  1/27 (3.70%)  1
Eyelid function disorder  1  1/27 (3.70%)  2
Watering eyes  1  2/27 (7.41%)  2
Gastrointestinal disorders   
Abdominal distension  1  1/27 (3.70%)  1
Abdominal pain  1  4/27 (14.81%)  10
Bloating  1  1/27 (3.70%)  16
Constipation  1  7/27 (25.93%)  56
Diarrhea  1  4/27 (14.81%)  14
Dry mouth  1  1/27 (3.70%)  14
Dyspepsia  1  1/27 (3.70%)  1
Dysphagia  1  1/27 (3.70%)  4
Hemorrhoids  1  1/27 (3.70%)  2
Mucositis oral  1  3/27 (11.11%)  13
Nausea  1  13/27 (48.15%)  88
Upper gastrointestinal hemorrhage  1  1/27 (3.70%)  1
Vomiting  1  5/27 (18.52%)  9
General disorders   
Chills  1  1/27 (3.70%)  3
Edema limbs  1  4/27 (14.81%)  13
Fatigue  1  22/27 (81.48%)  170
Fever  1  2/27 (7.41%)  3
Infusion site extravasation  1  2/27 (7.41%)  2
Localized edema  1  2/27 (7.41%)  10
Non-cardiac chest pain  1  4/27 (14.81%)  23
Pain  1  6/27 (22.22%)  10
Infections and infestations   
Anorectal infection  1  1/27 (3.70%)  6
Bronchial infection  1  1/27 (3.70%)  1
Eye infection  1  1/27 (3.70%)  2
Lung infection  1  1/27 (3.70%)  2
Prostate infection  1  1/27 (3.70%)  1
Skin infection  1  2/27 (7.41%)  14
Tooth infection  1  2/27 (7.41%)  3
Injury, poisoning and procedural complications   
Fall  1  1/27 (3.70%)  3
Investigations   
Alanine aminotransferase increased  1  5/27 (18.52%)  14
Alkaline phosphatase increased  1  3/27 (11.11%)  10
Aspartate aminotransferase increased  1  3/27 (11.11%)  5
CD4 lymphocytes decreased  1  1/27 (3.70%)  1
Creatinine increased  1  5/27 (18.52%)  11
GGT increased  1  1/27 (3.70%)  1
Lymphocyte count decreased  1  8/27 (29.63%)  68
Lymphocyte count increased  1  1/27 (3.70%)  3
Neutrophil count decreased  1  1/27 (3.70%)  1
Platelet count decreased  1  3/27 (11.11%)  6
Weight gain  1  1/27 (3.70%)  1
White blood cell decreased  1  2/27 (7.41%)  18
Metabolism and nutrition disorders   
Acidosis  1  1/27 (3.70%)  1
Anorexia  1  5/27 (18.52%)  8
Dehydration  1  1/27 (3.70%)  1
Hyperglycemia  1  8/27 (29.63%)  72
Hyperkalemia  1  2/27 (7.41%)  9
Hypernatremia  1  1/27 (3.70%)  3
Hypoalbuminemia  1  4/27 (14.81%)  37
Hypocalcemia  1  1/27 (3.70%)  1
Hypomagnesemia  1  2/27 (7.41%)  7
Hyponatremia  1  4/27 (14.81%)  26
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/27 (7.41%)  6
Arthritis  1  1/27 (3.70%)  4
Back pain  1  4/27 (14.81%)  8
Chest wall pain  1  2/27 (7.41%)  2
Flank pain  1  1/27 (3.70%)  14
Myalgia  1  1/27 (3.70%)  1
Pain in extremity  1  1/27 (3.70%)  4
Nervous system disorders   
Dizziness  1  4/27 (14.81%)  15
Peripheral motor neuropathy  1  1/27 (3.70%)  4
Peripheral sensory neuropathy  1  5/27 (18.52%)  31
Psychiatric disorders   
Anxiety  1  2/27 (7.41%)  27
Insomnia  1  1/27 (3.70%)  13
Renal and urinary disorders   
Chronic kidney disease  1  1/27 (3.70%)  5
Proteinuria  1  1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/27 (11.11%)  5
Dyspnea  1  6/27 (22.22%)  46
Nasal congestion  1  1/27 (3.70%)  8
Pleural effusion  1  1/27 (3.70%)  2
Pleuritic pain  1  1/27 (3.70%)  1
Productive cough  1  1/27 (3.70%)  1
Respiratory failure  1  1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/27 (3.70%)  1
Wheezing  1  1/27 (3.70%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  1/27 (3.70%)  14
Hyperhidrosis  1  1/27 (3.70%)  19
Purpura  1  1/27 (3.70%)  1
Rash maculo-papular  1  2/27 (7.41%)  5
Skin and subcutaneous tissue disorders - Other, specify  1  1/27 (3.70%)  5
Urticaria  1  1/27 (3.70%)  1
Vascular disorders   
Flushing  1  1/27 (3.70%)  3
Hot flashes  1  1/27 (3.70%)  21
Hypertension  1  2/27 (7.41%)  25
Hypotension  1  1/27 (3.70%)  2
Thromboembolic event  1  2/27 (7.41%)  5
Vascular disorders - Other, specify  1  1/27 (3.70%)  1
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Arkadiusz Z. Dudek M.D., Ph.D.
Organization: HealthPartners Cancer Care Center
Phone: 651 254-3321
EMail: Arkadiusz.Z.Dudek@HealthPartners.Com
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01085630    
Other Study ID Numbers: CALGB-30901
CALGB-30901
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000667496 ( Registry Identifier: NCI Physician Data Query )
First Submitted: March 11, 2010
First Posted: March 12, 2010
Results First Submitted: February 5, 2019
Results First Posted: March 5, 2019
Last Update Posted: August 7, 2020