Chemotherapy for Patients With Osteosarcoma

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. Identifier: NCT00523419
Recruitment Status : Completed
First Posted : August 31, 2007
Results First Posted : September 21, 2010
Last Update Posted : June 28, 2011
Information provided by:
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Osteosarcoma
Intervention: Drug: Pemetrexed

  Participant Flow

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
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
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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
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
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 42.1  (16.28) 
[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 
[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.
Eastern Cooperative Oncology Group (ECOG) performance status [1] 
[Units: Participants]
ECOG Performance Status 0   16 
ECOG Performance Status 1   14 
ECOG Performance Status 2   1 
ECOG Performance Status Not Available   1 
[1] 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.
Histopathological Diagnosis of Osteosarcoma at Study Entry 
[Units: Participants]
Number of Target Lesions [1] 
[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 
[1] 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.
Number of non target lesions [1] 
[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 
[1] 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.
Pathological Diagnosis of Osteosarcoma at Study Entry 
[Units: Participants]
Time from last diagnosis to enrollment 
[Units: Days]
Mean (Standard Deviation)
 13.3  (12.10) 

  Outcome Measures

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

2.  Secondary:   Time to Treatment Failure   [ Time Frame: Baseline to 21 months ]

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

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

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

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

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

  Serious Adverse Events

  Other Adverse Events

  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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  More Information

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.

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

Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT00523419     History of Changes
Other Study ID Numbers: 11814
H3E-EW-S115 ( Other Identifier: Eli Lilly and Company )
First Submitted: August 29, 2007
First Posted: August 31, 2007
Results First Submitted: June 23, 2010
Results First Posted: September 21, 2010
Last Update Posted: June 28, 2011