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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 
Overall Participants Analyzed 
[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 
[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.
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) 


  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
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Time Frame No text entered.
Additional Description 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.


Serious Adverse Events
    Bi-Weekly Schedule   21-Day Schedule
Total, serious adverse events     
# participants affected   17   7 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   2/52 (3.85%)   0/21 (0.00%) 
# events   2   0 
Febrile neutropenia † 1     
# participants affected / at risk   4/52 (7.69%)   1/21 (4.76%) 
# events   5   1 
Pancytopenia † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Thrombocytopenia † 1     
# participants affected / at risk   0/52 (0.00%)   1/21 (4.76%) 
# events   0   1 
Gastrointestinal disorders     
Abdominal pain † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Constipation † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
General disorders     
Pyrexia † 1     
# participants affected / at risk   2/52 (3.85%)   1/21 (4.76%) 
# events   3   1 
Hepatobiliary disorders     
Hepatic failure † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   2   0 
Hyperbilirubinaemia † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Infections and infestations     
Device related infection † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Pneumonia † 1     
# participants affected / at risk   2/52 (3.85%)   0/21 (0.00%) 
# events   2   0 
Sepsis † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Injury, poisoning and procedural complications     
Femur fracture † 1     
# participants affected / at risk   0/52 (0.00%)   1/21 (4.76%) 
# events   0   1 
Fracture † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Spinal compression fracture † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Investigations     
Drug level increased † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Metabolism and nutrition disorders     
Dehydration † 1     
# participants affected / at risk   2/52 (3.85%)   0/21 (0.00%) 
# events   2   0 
Hyponatraemia † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Hypovolaemia † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Nervous system disorders     
Convulsion † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Dizziness † 1     
# participants affected / at risk   0/52 (0.00%)   1/21 (4.76%) 
# events   0   1 
Lumbar radiculopathy † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Meningitis noninfective † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Psychiatric disorders     
Mental status changes † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1     
# participants affected / at risk   0/52 (0.00%)   1/21 (4.76%) 
# events   0   1 
Interstitial lung disease † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Pleural effusion † 1     
# participants affected / at risk   2/52 (3.85%)   0/21 (0.00%) 
# events   2   0 
Pneumonitis † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Pulmonary embolism † 1     
# participants affected / at risk   0/52 (0.00%)   1/21 (4.76%) 
# events   0   1 
Pulmonary oedema † 1     
# participants affected / at risk   0/52 (0.00%)   1/21 (4.76%) 
# events   0   1 
Respiratory failure † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Skin and subcutaneous tissue disorders     
Drug eruption † 1     
# participants affected / at risk   1/52 (1.92%)   0/21 (0.00%) 
# events   1   0 
Erythema † 1     
# participants affected / at risk   0/52 (0.00%)   1/21 (4.76%) 
# events   0   1 
Vascular disorders     
Aortic stenosis † 1     
# participants affected / at risk   0/52 (0.00%)   1/21 (4.76%) 
# events   0   1 
Superior vena caval occlusion † 1     
# participants affected / at risk   0/52 (0.00%)   1/21 (4.76%) 
# events   0   1 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 10




  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
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  More Information