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Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma
This study has been completed.
Study NCT00087698   Information provided by Eli Lilly and Company
First Received: July 12, 2004   Last Updated: May 1, 2009   History of Changes
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Condition: Pleural Neoplasms
Interventions: Drug: pemetrexed
Drug: cisplatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pemetrexed pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)

Participant Flow:   Overall Study
  Pemetrexed
STARTED   77  
COMPLETED   41  
NOT COMPLETED   36  
      Lack of Efficacy, Progressive Disease               14  
      Death from Other Causes               3  
      Adverse Event               4  
      Withdrawal by Subject               4  
      Lack of Efficacy, Physician Perception               3  
      Protocol Entry Criteria Not Met               2  
      Clinical Relapse               1  
      Death from Study Disease               2  
      Death from Study Drug Toxicity               2  
      Protocol Violation               1  



  Baseline Characteristics
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Reporting Groups
  Description
Pemetrexed pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)

Baseline Measures
  Pemetrexed
Number of Participants  
[units: participants]
 		77
Age  
[units: years]
Mean ± Standard Deviation 		61.1 ± 9.38
Gender  
[units: participants]
 		 
Female 21
Male 56
Region of Enrollment  
[units: participants]
 		 
United States 77
Disease Stage at Time of Study Entry  
[units: participants]
 		 
Stage IA 3
Stage IB 3
Stage II 33
Stage III 35
Stage IV 1
Unknown/Not Available 2
Eastern Cooperative Oncology Group Performance Status  
[units: participants]
 		 
0 - Fully active and asymptomatic 28
1 - Ambulatory with symptoms 47
2 - In bed < 50% of time 2
Initial Pathological Diagnosis  
[units: participants]
 		 
Epithelial Mesothelioma 62
Mixed Cell Mesothelioma 2
Sarcomatoid Mesothelioma 1
Other 12
Race/Ethnicity  
[units: participants]
 		 
Caucasian 71
African 1
East/Southeast Asian 1
Western Asian 2
Hispanic 2
Time from Initial Pathological Diagnosis to Enrollment  
[units: months]
Mean ± Standard Deviation 		2.19 ± 2.909



  Outcome Measures
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1.  Primary:   Pathological Complete Response   [ Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks) ]
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2.  Secondary:   The 1 and 2 Year Disease-Free Survival Rate (Percentage)   [ 1 year and 2 years ]
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3.  Secondary:   Overall Tumor Response   [ baseline to measured progressive disease ]
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4.  Secondary:   Time to Treatment Failure   [ baseline to stopping treatment ]
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5.  Secondary:   Time to Progressive Disease   [ baseline to measured progressive disease ]
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6.  Secondary:   Overall Survival Time   [ baseline to date of death from any cause ]
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  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Pemetrexed pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 Gy

Other Adverse Events
  Pemetrexed
Total, other (not including serious) adverse events  
# participants affected 77  
Blood and lymphatic system disorders  
Anaemia   † A
      # participants affected / at risk
      # events
17/77 (22.08%)
22  
Leukopenia   † A
      # participants affected / at risk
      # events
5/77 (6.49%)
8  
Neutropenia   † A
      # participants affected / at risk
      # events
8/77 (10.39%)
10  
Cardiac disorders  
Tachycardia   † A
      # participants affected / at risk
      # events
7/77 (9.09%)
7  
Ear and labyrinth disorders  
Tinnitus   † A
      # participants affected / at risk
      # events
12/77 (15.58%)
13  
Eye disorders  
Lacrimation increased   † A
      # participants affected / at risk
      # events
5/77 (6.49%)
5  
Vision blurred   † A
      # participants affected / at risk
      # events
5/77 (6.49%)
6  
Gastrointestinal disorders  
Abdominal distention   † A
      # participants affected / at risk
      # events
4/77 (5.19%)
6  
Abdominal pain   † A
      # participants affected / at risk
      # events
5/77 (6.49%)
6  
Constipation   † A
      # participants affected / at risk
      # events
45/77 (58.44%)
62  
Diarrhoea   † A
      # participants affected / at risk
      # events
20/77 (25.97%)
21  
Dyspepsia   † A
      # participants affected / at risk
      # events
8/77 (10.39%)
9  
Gastrooesophageal reflux disease   † A
      # participants affected / at risk
      # events
4/77 (5.19%)
4  
Nausea   † A
      # participants affected / at risk
      # events
57/77 (74.03%)
87  
Stomatitis   † A
      # participants affected / at risk
      # events
15/77 (19.48%)
15  
Vomiting   † A
      # participants affected / at risk
      # events
34/77 (44.16%)
47  
General disorders  
Chest discomfort   † A
      # participants affected / at risk
      # events
7/77 (9.09%)
8  
Chest pain   † A
      # participants affected / at risk
      # events
9/77 (11.69%)
10  
Chills   † A
      # participants affected / at risk
      # events
5/77 (6.49%)
5  
Fatigue   † A
      # participants affected / at risk
      # events
51/77 (66.23%)
79  
Oedema peripheral   † A
      # participants affected / at risk
      # events
9/77 (11.69%)
12  
Pain   † A
      # participants affected / at risk
      # events
5/77 (6.49%)
5  
Pyrexia   † A
      # participants affected / at risk
      # events
10/77 (12.99%)
12  
Immune system disorders  
Drug hypersensitivity   † A
      # participants affected / at risk
      # events
6/77 (7.79%)
8  
Investigations  
Blood creatinine increased   † A
      # participants affected / at risk
      # events
6/77 (7.79%)
8  
Breath sounds abnormal   † A
      # participants affected / at risk
      # events
8/77 (10.39%)
8  
Haemoglobin decreased   † A
      # participants affected / at risk
      # events
4/77 (5.19%)
4  
Weight decreased   † A
      # participants affected / at risk
      # events
4/77 (5.19%)
5  
White blood cell count decreased   † A
      # participants affected / at risk
      # events
4/77 (5.19%)
4  
Metabolism and nutrition disorders  
Anorexia   † A
      # participants affected / at risk
      # events
22/77 (28.57%)
25  
Decreased appetite   † A
      # participants affected / at risk
      # events
6/77 (7.79%)
6  
Dehydration   † A
      # participants affected / at risk
      # events
4/77 (5.19%)
4  
Hypercholesterolaemia   † A
      # participants affected / at risk
      # events
4/77 (5.19%)
4  
Hyperglycaemia   † A
      # participants affected / at risk
      # events
6/77 (7.79%)
7  
Hypomagnesaemia   † A
      # participants affected / at risk
      # events
6/77 (7.79%)
8  
Musculoskeletal and connective tissue disorders  
Arthralgia   † A
      # participants affected / at risk
      # events
10/77 (12.99%)
10  
Back pain   † A
      # participants affected / at risk
      # events
5/77 (6.49%)
6  
Musculoskeletal pain   † A
      # participants affected / at risk
      # events
4/77 (5.19%)
4  
Myalgia   † A
      # participants affected / at risk
      # events
5/77 (6.49%)
5  
Nervous system disorders  
Dizziness   † A
      # participants affected / at risk
      # events
7/77 (9.09%)
7  
Dysgeusia   † A
      # participants affected / at risk
      # events
16/77 (20.78%)
16  
Headache   † A
      # participants affected / at risk
      # events
10/77 (12.99%)
13  
Neuropathy   † A
      # participants affected / at risk
      # events
5/77 (6.49%)
6  
Parosmia   † A
      # participants affected / at risk
      # events
4/77 (5.19%)
4  
Peripheral sensory neuropathy   † A
      # participants affected / at risk
      # events
5/77 (6.49%)
5  
Psychiatric disorders  
Anxiety   † A
      # participants affected / at risk
      # events
8/77 (10.39%)
8  
Insomnia   † A
      # participants affected / at risk
      # events
10/77 (12.99%)
10  
Renal and urinary disorders  
Pollakiuria   † A
      # participants affected / at risk
      # events
4/77 (5.19%)
4  
Respiratory, thoracic and mediastinal disorders  
Cough   † A
      # participants affected / at risk
      # events
18/77 (23.38%)
19  
Dyspnoea   † A
      # participants affected / at risk
      # events
12/77 (15.58%)
12  
Epistaxis   † A
      # participants affected / at risk
      # events
5/77 (6.49%)
5  
Hiccups   † A
      # participants affected / at risk
      # events
6/77 (7.79%)
6  
Skin and subcutaneous tissue disorders  
Alopecia   † A
      # participants affected / at risk
      # events
8/77 (10.39%)
8  
Night sweats   † A
      # participants affected / at risk
      # events
6/77 (7.79%)
6  
Rash   † A
      # participants affected / at risk
      # events
18/77 (23.38%)
24  
Vascular disorders  
Flushing   † A
      # participants affected / at risk
      # events
5/77 (6.49%)
5  
Hypertension   † A
      # participants affected / at risk
      # events
6/77 (7.79%)
6  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA 10


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979


No publications provided


Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 7216, H3E-US-JMGA
Study First Received: July 12, 2004
Results First Received: February 16, 2009
Last Updated: May 1, 2009
ClinicalTrials.gov Identifier: NCT00087698     History of Changes
Health Authority: United States: Food and Drug Administration





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