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Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane Therapy

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00063570
First received: June 30, 2003
Last updated: May 12, 2009
Last verified: May 2009
Results First Received: January 27, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Breast Cancer
Breast Neoplasms
Interventions: Drug: Pemetrexed
Drug: Gemcitabine

  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
At completion of the first stage of the trial, toxicities associated with the Day 8 dosing of gemcitabine were observed, and the protocol was amended to a bi-weekly schedule. Patients were analyzed separately according to the study drug schedule received.

Reporting Groups
  Description
Bi-Weekly Schedule

Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.

Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.

21-Day Schedule

Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.

Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.


Participant Flow:   Overall Study
    Bi-Weekly Schedule     21-Day Schedule  
STARTED     52     21  
COMPLETED     52 [1]   21 [1]
NOT COMPLETED     0     0  
[1] Completed for this study means patient received study drug and was eligible for efficacy analysis.



  Baseline Characteristics
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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
Bi-Weekly Schedule

Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.

Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.

21-Day Schedule

Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.

Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.

Total Total of all reporting groups

Baseline Measures
    Bi-Weekly Schedule     21-Day Schedule     Total  
Number of Participants  
[units: participants]
  52     21     73  
Age  
[units: years]
Median ( Full Range )
  53.5  
  ( 33 to 73 )  
  50.7  
  ( 28 to 73 )  
  51.9  
  ( 28 to 73 )  
Gender  
[units: participants]
     
Female     52     21     73  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     52     21     73  
Current Pathological Diagnosis  
[units: paticipants]
     
Ductal breast carcinoma     36     12     48  
Lobular breast carcinoma     2     0     2  
Adenocystic breast carcinoma     0     1     1  
Breast carcinoma     4     4     8  
Other     7     3     10  
Unknown     1     1     2  
No current pathological diagnosis     2     0     2  
Karnofsky Performance Status (KPS) [1]
[units: participants]
     
<=60 - Needs increasing assistance up to Death (0)     0     0     0  
70 - Unable to carry on normal activity     4     1     5  
80 - Activity with effort; some signs of disease     11     5     16  
90 - Normal activity; minor signs of disease     19     9     28  
100 - Normal no complaints; no evidence of disease     17     6     23  
unknown     1     0     1  
Menopausal Status at Cycle 0  
[units: participants]
     
Pre-Menopausal     7     3     10  
Menopausal     4     3     7  
Post-Menopausal     41     15     56  
Patients with Current Pathological Diagnosis  
[units: participants]
     
Yes     50     21     71  
No     2     0     2  
Race/Ethnicity  
[units: participants]
     
Caucasian     44     20     64  
African     4     1     5  
East/Southeast Asian     3     0     3  
Hispanic     1     0     1  
Time (in months) from Current Pathological Diagnosis to Enrollment  
[units: Months]
Median ( Full Range )
  13.08  
  ( 0.4 to 134.2 )  
  14.31  
  ( 0.5 to 57.1 )  
  14.29  
  ( 0.4 to 134.2 )  
[1] The Karnofsky Performance Status Index classifies functional impairment. Scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities.



  Outcome Measures
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1.  Primary:   Overall Tumor Response   [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ]

2.  Secondary:   Duration of (Confirmed) Complete Response or Partial Response   [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ]

3.  Secondary:   Time to Progressive Disease   [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ]

4.  Secondary:   Time to Treatment Failure   [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ]

5.  Secondary:   Overall Survival   [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00063570     History of Changes
Other Study ID Numbers: 5141, H3E-US-JMEO
Study First Received: June 30, 2003
Results First Received: January 27, 2009
Last Updated: May 12, 2009
Health Authority: United States: Food and Drug Administration