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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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)

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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Time Frame	No text entered.
Additional Description	No text entered.

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

Serious Adverse Events

	Pemetrexed
Total, serious adverse events
# participants affected	15
Blood and lymphatic system disorders
Febrile neutropenia ^†^A # participants affected / at risk # events	2/77 (2.60%) 2
Cardiac disorders
Atrial fibrillation ^†^A # participants affected / at risk # events	1/77 (1.30%) 1
Sinus bradycardia ^†^A # participants affected / at risk # events	1/77 (1.30%) 1
Gastrointestinal disorders
Vomiting ^†^A # participants affected / at risk # events	2/77 (2.60%) 2
General disorders
Chest pain ^†^A # participants affected / at risk # events	1/77 (1.30%) 3
Death ^†^A # participants affected / at risk # events	1/77 (1.30%) 1
Infections and infestations
Infection ^†^A # participants affected / at risk # events	1/77 (1.30%) 1
Pneumonia ^†^A # participants affected / at risk # events	4/77 (5.19%) 5
Investigations
Blood creatinine increased ^†^A # participants affected / at risk # events	2/77 (2.60%) 2
Metabolism and nutrition disorders
Anorexia ^†^A # participants affected / at risk # events	1/77 (1.30%) 1
Dehydration ^†^A # participants affected / at risk # events	1/77 (1.30%) 1
Hypomagnesaemia ^†^A # participants affected / at risk # events	1/77 (1.30%) 1
Renal and urinary disorders
Renal failure ^†^A # participants affected / at risk # events	1/77 (1.30%) 1
Respiratory, thoracic and mediastinal disorders
Pleural effusion ^†^A # participants affected / at risk # events	1/77 (1.30%) 1
Pleuritic pain ^†^A # participants affected / at risk # events	2/77 (2.60%) 2
Pulmonary embolism ^†^A # participants affected / at risk # events	2/77 (2.60%) 2
Respiratory failure ^†^A # participants affected / at risk # events	1/77 (1.30%) 1
Vascular disorders
Deep vein thrombosis ^†^A # participants affected / at risk # events	1/77 (1.30%) 1

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA 10

Other Adverse Events

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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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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
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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