Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pemetrexed-Carboplatin and Gemcitabine-Vinorelbine in Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00325234
First received: May 10, 2006
Last updated: April 26, 2011
Last verified: April 2011
Results First Received: April 26, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Pemetrexed
Drug: Carboplatin
Drug: Gemcitabine
Drug: Vinorelbine

  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/Carboplatin Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
Gemcitabine/Vinorelbine

Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.

Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.


Participant Flow:   Overall Study
    Pemetrexed/Carboplatin   Gemcitabine/Vinorelbine
STARTED   69   66 
Received At Least 1 Dose of Study Drug   65   66 
COMPLETED   0   0 
NOT COMPLETED   69   66 
Adverse Event                10                7 
Death due to Study Disease                1                0 
Entry Criteria Not Met                1                2 
Subject Decision                6                8 
Physician Decision                17                12 
Progressive Disease                34                37 



  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/Carboplatin Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
Gemcitabine/Vinorelbine

Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.

Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.

Total Total of all reporting groups

Baseline Measures
   Pemetrexed/Carboplatin   Gemcitabine/Vinorelbine   Total 
Overall Participants Analyzed 
[Units: Participants]
 69   66   135 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.9  (11.38)   52.3  (10.40)   52.1  (10.87) 
Gender 
[Units: Participants]
     
Female   69   66   135 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   67   61   128 
African   1   3   4 
Hispanic   0   1   1 
East Asian   1   0   1 
West Asian   0   1   1 
Region of Enrollment 
[Units: Participants]
     
Spain   18   18   36 
Switzerland   5   4   9 
Israel   9   9   18 
Germany   9   12   21 
Italy   16   14   30 
Turkey   5   3   8 
South Africa   7   6   13 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
     
ECOG 0   39   39   78 
ECOG 1   28   27   55 
ECOG 2   2   0   2 
[1]

The Eastern Cooperative Oncology Group (ECOG) scales and criteria are used by doctors to assess disease progression, assess the patient’s living ability, and determine prognosis. The scale is as follows:

0-Fully active, able to carry on all pre-disease performance without restriction. 1-Restricted in activity but ambulatory and able to perform sedentary work. 2-Ambulatory but unable to work. Up and about > 50% of waking hours. 3-Capable of only limited selfcare, confined to bed or chair > 50% of waking hours. 4-Completely disabled. Cannot self care. Totally confined to bed or chair. 5-Dead

Hormonal Receptor Status [1] 
[Units: Participants]
     
Estrogen and Progesterone Negative   19   21   40 
Estrogen and/or Progesterone Positive   49   44   93 
Unknown   1   1   2 
[1] Hormone receptor status is a positive or negative measure of estrogen (ER) or progesterone (PR) hormone receptors found in cancer cells. In hormone receptor negative tumors, estrogen and/or progesterone are not present in cancer cells. In hormone receptor positive tumors, estrogen and/or progesterone hormone receptors are present in the cancer cells.
Human Epidermal Growth Factor Receptor 2 (HER-2/Neu) [1] 
[Units: Participants]
     
Positive   12   13   25 
Negative   53   49   102 
Not Performed   0   1   1 
Unknown   4   3   7 
[1] The Human Epidermal Growth Factor Receptor 2 plays an important role in cell growth and development. HER-2/Neu status is determined by an assay. A positive HER-2/Neu result indicates that HER-2 gene receptors are present; negative HER-2/Neu indicates the absence of HER-2 gene receptors.
Tumor Differentiation Grade [1] 
[Units: Participants]
     
Grade I   6   3   9 
Grade II   25   27   52 
Grade III   32   30   62 
Unknown   6   6   12 
[1]

Classification of tumors into one of four grades based upon how similar in appearance the tumor cells are to normal cells, and by how many tumor cells are dividing. The more tumor cells that are dividing, the greater likelihood of tumor growth and the higher the tumor grade. A lower tumor grade is associated with a better prognosis.

Grade 1 - Well-Differentiated, Low cell division Grade 2 - Moderately Differentiated, Moderate cell division Grade 3 - Poorly Differentiated, High cell division Grade 4 - Undifferentiated, High cell division

Pathological Diagnosis [1] 
[Units: Participants]
     
Carcinoma, Ductal, Breast   64   54   118 
Carcinoma, Lobular, Breast   4   5   9 
Carcinoma, Inflammatory, Breast   1   3   4 
Carcinoma, Mixed Cell, Breast   0   1   1 
Other   0   3   3 
[1] This measure is the specific diagnosis of breast cancer based upon pathological diagnosis.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tumor Response Rate   [ Time Frame: Baseline up to 30 days of follow-up after 21 cycles of treatment ]

2.  Secondary:   Duration of Response (DOR)   [ Time Frame: Time of response to progressive disease (up to 19 months) ]

3.  Secondary:   Time to Progressive Disease (PD)   [ Time Frame: Baseline to measured PD (up to 25.1 months) ]

4.  Secondary:   Time To Treatment Failure (TTTF)   [ Time Frame: Baseline to end of treatment (up to 21.9 months) ]

5.  Secondary:   Time to Response   [ Time Frame: Baseline to response (up to 7.8 months) ]

6.  Secondary:   Number of Participants With Adverse Events (AE)   [ Time Frame: every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up) ]


  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



Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00325234     History of Changes
Other Study ID Numbers: 10826
H3E-EW-S098 ( Other Identifier: Eli Lilly and Company )
Study First Received: May 10, 2006
Results First Received: April 26, 2011
Last Updated: April 26, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Turkey: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic