Chemotherapy for Patients With Osteosarcoma

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00523419

First received: August 29, 2007

Last updated: June 24, 2011

Last verified: June 2011

History of Changes

Results First Received: June 23, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Osteosarcoma
Intervention:	Drug: Pemetrexed

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	Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle

Participant Flow: Overall Study

	Pemetrexed
STARTED	32
COMPLETED	0
NOT COMPLETED	32
Adverse Event	1
Withdrawal by Subject	1
Physician Decision	2
Progressive Disease	22
Death due to Study Disease	4
Death due to Adverse Event	2

Baseline Characteristics

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Reporting Groups

	Description
Pemetrexed	Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle

Baseline Measures

	Pemetrexed
Number of Participants [units: participants]	32
Age [units: years] Mean ± Standard Deviation	42.1 ± 16.28
Gender [units: participants]
Female	12
Male	20
Region of Enrollment [units: participants]
France	13
Spain	3
Germany	6
United Kingdom	1
Italy	9
Best Response of Last Prior Treatment Regimen for Osteosarcoma ^[1] [units: participants]
Complete Response	1
Partial Response	3
Stable Disease	10
Progressive Disease	15
Not Applicable	3
Eastern Cooperative Oncology Group (ECOG) performance status ^[2] [units: participants]
ECOG Performance Status 0	16
ECOG Performance Status 1	14
ECOG Performance Status 2	1
ECOG Performance Status Not Available	1
Histopathological Diagnosis of Osteosarcoma at Study Entry [units: participants]	32
Number of Target Lesions ^[3] [units: participants]
0 Target Lesions	1
1 Target Lesion	9
2 Target Lesions	8
3 Target Lesions	4
4 Target Lesions	3
5 Target Lesions	7
Number of non target lesions ^[4] [units: participants]
0 Non Target Lesions	10
1 Non Target Lesion	15
2 Non Target Lesions	5
3 Non Target Lesions	1
5 Non Target Lesions	1
Pathological Diagnosis of Osteosarcoma at Study Entry [units: participants]	32
Time from last diagnosis to enrollment [units: days] Mean ± Standard Deviation	13.3 ± 12.10

[1]	Complete response (CR): all tumor lesions disappear. Partial response (PR): >=30% decrease in sum of the longest diameter (LD) of target lesions (reference: baseline sum LDs) or complete disappearance of target lesions, with persistence (but not worsening) of >=1 nontarget lesions; no appearance of new lesions. Stable disease: neither sufficient shrinkage for PR nor sufficient increase for PD; references: smallest sum LD. Progressive disease (PD): >=20% increase in the sum of LD of target lesions (references: smallest sum LD recorded since treatment started) or appearance of >=1 new lesions.
[2]	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; 2: ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3: capable of only 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; 5: dead.
[3]	Target lesions: all measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs; selected on the basis of size (those lesions with the longest diameter) and suitability for accurate repeated measurements (either by imaging techniques or clinically). If the measurable disease is restricted to a solitary lesion, the neoplastic nature of the lesion was confirmed by cytology/histology.
[4]	All lesions that do not meet the criteria for target lesions, including small lesions (longest diameter <20 millimeter [mm] with conventional computed tomography [CT] scan, <10 mm with spiral CT scan) and other non-measurable lesions.

Outcome Measures

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1. Primary:

Percentage of Participants With Tumor Response [ Time Frame: Baseline to 21 months ]

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2. Secondary:

Time to Treatment Failure [ Time Frame: Baseline to 21 months ]

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3. Secondary:

Correlation of Disease Outcome With Pharmacogenomic Analysis [ Time Frame: Baseline to 21 months ]

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4. Secondary:

Number of Participants With Adverse Events (Pharmacology Toxicity) [ Time Frame: Baseline to 21 months ]

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5. Secondary:

Duration of Response [ Time Frame: Baseline to 31 months ]

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6. Secondary:

Progression-Free Survival (PFS) [ Time Frame: Baseline to 10.4 months ]

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7. Secondary:

Overall Survival (OS) Time [ Time Frame: Baseline to 27.6 months ]

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Serious Adverse Events

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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: 800-545-5979

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00523419 History of Changes
Other Study ID Numbers:	11814, H3E-EW-S115
Study First Received:	August 29, 2007
Results First Received:	June 23, 2010
Last Updated:	June 24, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: The Italian Medicines Agency Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency

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