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
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
  Hide Participant Flow

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 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
  Hide 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.
No text entered.

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
  Show All 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
  Hide 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.


  More Information
  Hide 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


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