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A Phase III Trial For Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191152
First received: September 12, 2005
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
Results First Received: November 4, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Breast Cancer
Breast Neoplasms
Cancer of the Breast
Interventions: Drug: gemcitabine
Drug: docetaxel
Drug: capecitabine

  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
Not all participants who completed initial treatment went on to crossover treatment. Per protocol, participants had the option to go off study without receiving crossover treatment.

Reporting Groups
  Description
Gemcitabine Plus Docetaxel

Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2),intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.

Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued. PD during crossover was defined as the Response Evaluation Criteria in Solid Tumors (RECIST) guideline with the tumor measurement at the start of crossover treatment (or end of initial treatment) considered as the crossover baseline, with subsequent tumor measurements during crossover treatment compared to the crossover baseline.
Docetaxel Plus Capecitabine

Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.

Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued.

Participant Flow for 2 periods

 Period 1:   Initial Treatment
    Gemcitabine Plus Docetaxel     Docetaxel Plus Capecitabine  
STARTED     239     236  
Received Initial Treatment     236     227  
COMPLETED     98     83  
NOT COMPLETED     141     153  
Adverse Event                 43                 67  
Physician Decision                 40                 31  
Withdrawal by Subject                 40                 28  
Lost to Follow-up                 0                 6  
not specified                 18                 21  

Period 2:   Crossover Treatment
    Gemcitabine Plus Docetaxel     Docetaxel Plus Capecitabine  
STARTED     77     81  
Received Treatment     76     80  
COMPLETED     50     53  
NOT COMPLETED     27     28  
Adverse Event                 8                 8  
Physician Decision                 7                 7  
Withdrawal by Subject                 6                 9  
Lost to Follow-up                 2                 1  
Not Specified                 4                 3  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Gemcitabine Plus Docetaxel

Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.

Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO)twice a day (BID), Days 1-14, every 21 days until progressive disease (PD) at which time all treatment is discontinued.
Docetaxel Plus Capecitabine

Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID),Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.

Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued.
Total Total of all reporting groups

Baseline Measures
    Gemcitabine Plus Docetaxel     Docetaxel Plus Capecitabine     Total  
Number of Participants  
[units: participants]
 		  239     236     475  
Age  
[units: years]
Mean ± Standard Deviation 		  55.8  ± 11.77     54.6  ± 11.60     55.2  ± 11.69  
Gender  
[units: participants]
 		     
Female     237     1     238  
Male     2     235     237  
Region of Enrollment  
[units: participants]
 		     
United States     173     166     339  
Taiwan     15     18     33  
Mexico     14     15     29  
Puerto Rico     4     1     5  
Argentina     11     13     24  
Brazil     1     1     2  
Australia     11     12     23  
Korea, Republic of     10     10     20  
Karnofsky Performance Status-Baseline [1]
[units: units on a scale]
 		     
<=60 Needs increasing assistance up to Death (0)     0     0     0  
70 - Unable to carry on normal activity     16     15     31  
80 - Activity with effort; some signs of disease     44     40     84  
90 - Normal activity; minor signs of disease     101     101     202  
100 - Normal no complaints; no evidence of disease     74     75     149  
Missing     4     5     9  
Race/Ethnicity  
[units: participants]
 		     
Caucasian     160     158     318  
African Descent     23     12     35  
Oriental     28     30     58  
Hispanic     26     36     62  
Other     2     0     2  
[1] Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses.



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Time to Disease Progression (Initial Treatment)   [ Time Frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months) ]

Measure Type Primary
Measure Title Time to Disease Progression (Initial Treatment)
Measure Description Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.
Time Frame Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)  
Safety Issue No  

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.
Intent-to-treat (ITT) population: all randomized participants. Censored participants in initial treatment: 68 gemcitabine/docetaxel arm; 83 docetaxel/capecitabine arm.

Reporting Groups
  Description
Gemcitabine Plus Docetaxel

gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.

Treatment continues until progression of disease at which time crossover treatment begins.
Docetaxel Plus Capecitabine docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.

Measured Values
    Gemcitabine Plus Docetaxel     Docetaxel Plus Capecitabine  
Number of Participants Analyzed  
[units: participants]
 		  239     236  
Time to Disease Progression (Initial Treatment)  
[units: months]
Median ( 95% Confidence Interval ) 		  9.28  
  ( 7.73 to 10.79 )   		  8.88  
  ( 7.37 to 11.05 )  


Statistical Analysis 1 for Time to Disease Progression (Initial Treatment)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.385
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Secondary:   Time to Disease Progression (Crossover Treatment)   [ Time Frame: Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months) ]

Measure Type Secondary
Measure Title Time to Disease Progression (Crossover Treatment)
Measure Description For crossover treatment, time to disease progression (TTDP) was defined as the number of months between the first dose date of crossover treatment and the date of disease progression or the date of death due to disease under study, whichever came first. TTDP for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. TTDP censored at earliest of: 1)date of death not due to disease; or 2)date of last contact for participants alive without disease progression; or 3)start date of other anti-tumor therapy due to progression.
Time Frame Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)  
Safety Issue No  

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.
ITT population: all randomized participants. Censored participants in crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.

Reporting Groups
  Description
Capecitabine capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
Gemcitabine gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.

Measured Values
    Capecitabine     Gemcitabine  
Number of Participants Analyzed  
[units: participants]
 		  77     81  
Time to Disease Progression (Crossover Treatment)  
[units: months]
Median ( 95% Confidence Interval ) 		  4.51  
  ( 2.11 to 7.80 )   		  2.34  
  ( 2.04 to 3.78 )  


Statistical Analysis 1 for Time to Disease Progression (Crossover Treatment)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.145
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Secondary:   Progression-Free Survival (Initial Treatment)   [ Time Frame: Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months) ]

Measure Type Secondary
Measure Title Progression-Free Survival (Initial Treatment)
Measure Description For initial treatment, progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. Time to PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for progression; or 3) first dose date of crossover treatment.
Time Frame Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)  
Safety Issue No  

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.
ITT: all randomized participants. Censored participants (initial treatment): 64 in gemcitabine/docetaxel arm; 80 in docetaxel/capecitabine arm.

Reporting Groups
  Description
Gemcitabine Plus Docetaxel gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
Docetaxel Plus Capecitabine docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.

Measured Values
    Gemcitabine Plus Docetaxel     Docetaxel Plus Capecitabine  
Number of Participants Analyzed  
[units: participants]
 		  239     236  
Progression-Free Survival (Initial Treatment)  
[units: months]
Median ( 95% Confidence Interval ) 		  9.01  
  ( 7.73 to 10.53 )   		  8.88  
  ( 7.27 to 10.89 )  


Statistical Analysis 1 for Progression-Free Survival (Initial Treatment)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.361
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



4.  Secondary:   Progression-Free Survival (Crossover Treatment)   [ Time Frame: First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months) ]

Measure Type Secondary
Measure Title Progression-Free Survival (Crossover Treatment)
Measure Description For crossover treatment, progression-free survival (PFS) was defined as the number of months between first dose date of crossover treatment and date of documented disease progression or date of death due to any cause, whichever came first. PFS for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for participants with documented disease progression.
Time Frame First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)  
Safety Issue No  

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.
ITT population: all randomized participants. Censored participants, crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.

Reporting Groups
  Description
Capecitabine capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
Gemcitabine gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.

Measured Values
    Capecitabine     Gemcitabine  
Number of Participants Analyzed  
[units: participants]
 		  77     81  
Progression-Free Survival (Crossover Treatment)  
[units: months]
Median ( 95% Confidence Interval ) 		  4.51  
  ( 2.11 to 7.80 )   		  2.34  
  ( 2.04 to 3.78 )  


Statistical Analysis 1 for Progression-Free Survival (Crossover Treatment)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.145
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Secondary:   Duration of Response (Initial Treatment)   [ Time Frame: Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months) ]

Measure Type Secondary
Measure Title Duration of Response (Initial Treatment)
Measure Description Among tumor responders, duration of tumor response was measured from the date of response (complete response [CR] or partial response [PR] until the first date of documented progression or death from any cause. Duration of response was censored at the earliest of: 1) date of last contact for participants alive without disease progression (DP); or 2) start date of other anti-tumor therapy for DP; or 3) dose date of crossover treatment.
Time Frame Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)  
Safety Issue No  

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.
ITT population: participants with CR or PR as best overall response (initial treatment). Censored participants: 16 in gemcitabine/docetaxel arm; 30 in docetaxel/capecitabine arm.

Reporting Groups
  Description
Gemcitabine Plus Docetaxel gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
Docetaxel Plus Capecitabine docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.

Measured Values
    Gemcitabine Plus Docetaxel     Docetaxel Plus Capecitabine  
Number of Participants Analyzed  
[units: participants]
 		  77     85  
Duration of Response (Initial Treatment)  
[units: months]
Median ( 95% Confidence Interval ) 		  9.11  
  ( 7.60 to 11.94 )   		  10.39  
  ( 8.22 to 13.75 )  


Statistical Analysis 1 for Duration of Response (Initial Treatment)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.377
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



6.  Secondary:   Duration of Response (Crossover Treatment)   [ Time Frame: Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months) ]

Measure Type Secondary
Measure Title Duration of Response (Crossover Treatment)
Measure Description At crossover treatment, duration of response was measured from the time criteria were met for complete response (CR) or partial response (PR), until first date that recurrent or progressive disease was objectively documented or date of death due to any cause, whichever came first. This definition only applied to those who crossed over & achieved CR or PR in crossover treatment. Duration of response censored at earliest of: 1) date of last contact for those alive without disease progression; or 2) start date of other anti-tumor therapy for documented disease progression.
Time Frame Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)  
Safety Issue No  

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.
ITT population: participants with CR or PR as best overall response at crossover treatment. Censored participants: 4 in capecitabine arm; 2 in gemcitabine arm.

Reporting Groups
  Description
Capecitabine capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
Gemcitabine gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.

Measured Values
    Capecitabine     Gemcitabine  
Number of Participants Analyzed  
[units: participants]
 		  11     7  
Duration of Response (Crossover Treatment)  
[units: months]
Median ( 95% Confidence Interval ) 		  25.89  
  ( 4.64 to 45.03 )   		  42.50  
  ( 16.02 to 48.22 )  


Statistical Analysis 1 for Duration of Response (Crossover Treatment)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.446
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



7.  Secondary:   Overall Survival   [ Time Frame: Date of randomization to date of death from any cause (up to 82 months) ]

Measure Type Secondary
Measure Title Overall Survival
Measure Description Overall survival time was defined as the number of months between the date of randomization and the date of death due to any cause. The overall survival time was censored at the date of last contact for participants who were still alive.
Time Frame Date of randomization to date of death from any cause (up to 82 months)  
Safety Issue No  

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.
Intent to treat population: all randomized participant. Censored participants: 75 in gemcitabine/docetaxel arm; 72 in docetaxel/capecitabine arm.

Reporting Groups
  Description
Gemcitabine Plus Docetaxel gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
Docetaxel Plus Capecitabine docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.

Measured Values
    Gemcitabine Plus Docetaxel     Docetaxel Plus Capecitabine  
Number of Participants Analyzed  
[units: participants]
 		  239     236  
Overall Survival  
[units: months]
Median ( 95% Confidence Interval ) 		  22.99  
  ( 18.82 to 25.69 )   		  23.29  
  ( 18.55 to 25.53 )  


Statistical Analysis 1 for Overall Survival
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.785
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



8.  Secondary:   Best Overall Response (Initial Treatment)   [ Time Frame: Best response from start of treatment until disease progression/recurrence (up to 82 months) ]

Measure Type Secondary
Measure Title Best Overall Response (Initial Treatment)
Measure Description Best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.
Time Frame Best response from start of treatment until disease progression/recurrence (up to 82 months)  
Safety Issue No  

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.
ITT population.

Reporting Groups
  Description
Gemcitabine Plus Docetaxel gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
Docetaxel Plus Capecitabine docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.

Measured Values
    Gemcitabine Plus Docetaxel     Docetaxel Plus Capecitabine  
Number of Participants Analyzed  
[units: participants]
 		  239     236  
Best Overall Response (Initial Treatment)  
[units: participants]
 		   
Complete Response (confirmed)     6     6  
Partial Response (confirmed)     71     79  
Stable Disease     96     90  
Progressive Disease     32     27  
Unknown     34     34  


Statistical Analysis 1 for Best Overall Response (Initial Treatment)
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.364
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



9.  Secondary:   Best Overall Response (Crossover Treatment)   [ Time Frame: Best response from start of treatment until disease progression/recurrence (up to 82 months) ]

Measure Type Secondary
Measure Title Best Overall Response (Crossover Treatment)
Measure Description Best overall response was the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response assessed using RECIST criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.
Time Frame Best response from start of treatment until disease progression/recurrence (up to 82 months)  
Safety Issue No  

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.
Only included participants who crossed over from initial treatment to crossover treatment.

Reporting Groups
  Description
Capecitabine capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
Gemcitabine gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.

Measured Values
    Capecitabine     Gemcitabine  
Number of Participants Analyzed  
[units: participants]
 		  77     81  
Best Overall Response (Crossover Treatment)  
[units: participants]
 		   
Complete Response (confirmed)     1     1  
Partial Response (confirmed)     10     6  
Stable Disease     19     20  
Progressive Disease     34     36  
Unknown     13     18  


Statistical Analysis 1 for Best Overall Response (Crossover Treatment)
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.446
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



10.  Secondary:   Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)   [ Time Frame: Baseline until crossover treatment began (up to 82 months) ]

Measure Type Secondary
Measure Title Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)
Measure Description KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).
Time Frame Baseline until crossover treatment began (up to 82 months)  
Safety Issue No  

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.
Intent-to-treat population, initial treatment, participants with KPS at baseline and end of initial treatment.

Reporting Groups
  Description
Gemcitabine Plus Docetaxel gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
Docetaxel Plus Capecitabine docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.

Measured Values
    Gemcitabine Plus Docetaxel     Docetaxel Plus Capecitabine  
Number of Participants Analyzed  
[units: participants]
 		  212     214  
Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     90.85  ± 8.159     90.09  ± 8.335  
Change from Baseline     -3.30  ± 9.259     -3.27  ± 9.118  


Statistical Analysis 1 for Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] 0.990
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



11.  Secondary:   Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)   [ Time Frame: First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths) ]

Measure Type Secondary
Measure Title Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)
Measure Description KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).
Time Frame First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths)  
Safety Issue No  

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.
Participants with KPS at baseline (conclusion of initial treatment) and end of crossover treatment

Reporting Groups
  Description
Capecitabine capecitabine 1000 mg/m2, by mouth two times per day, days 1-14, every 21 days
Gemcitabine gemcitabine 1000 mg/m2 intravenously, days 1 and 8, every 21 days

Measured Values
    Capecitabine     Gemcitabine  
Number of Participants Analyzed  
[units: participants]
 		  66     63  
Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     89.09  ± 7.174     87.94  ± 9.360  
Change from Baseline     -0.30  ± 7.839     -1.27  ± 9.068  


Statistical Analysis 1 for Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] 0.117
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



12.  Secondary:   Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)   [ Time Frame: Baseline until crossover treatment began (up to 82 months) ]

Measure Type Secondary
Measure Title Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)
Measure Description RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].
Time Frame Baseline until crossover treatment began (up to 82 months)  
Safety Issue No  

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.
Participants with RSCL at baseline and end of initial treatment.

Reporting Groups
  Description
Gemcitabine Plus Docetaxel gemcitabine 1000 mg/m2, intravenous, on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, on Day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
Docetaxel Plus Capecitabine docetaxel 75 mg/m2, intravenous on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth, twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.

Measured Values
    Gemcitabine Plus Docetaxel     Docetaxel Plus Capecitabine  
Number of Participants Analyzed  
[units: participants]
 		  117     118  
Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     68.09  ± 25.103     72.32  ± 23.693  
Change from Baseline     2.42  ± 27.093     -2.68  ± 26.685  


Statistical Analysis 1 for Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] 0.801
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



13.  Secondary:   Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)   [ Time Frame: First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months) ]

Measure Type Secondary
Measure Title Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)
Measure Description RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].
Time Frame First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)  
Safety Issue No  

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.
Participants with RSCL at baseline (conclusion of initial treatment)and end of crossover treatment

Reporting Groups
  Description
Capecitabine capecitabine 1000 mg/m2, by mouth twice day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
Gemcitabine gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.

Measured Values
    Capecitabine     Gemcitabine  
Number of Participants Analyzed  
[units: participants]
 		  30     24  
Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     75.00  ± 20.876     76.39  ± 17.663  
Change from Baseline     -2.78  ± 21.029     -0.69  ± 27.133  


Statistical Analysis 1 for Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] 0.190
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


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: NCT00191152     History of Changes
Other Study ID Numbers: 4703, B9E-US-S188
Study First Received: September 12, 2005
Results First Received: November 4, 2009
Last Updated: December 21, 2009
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Mexico: Federal Commission for Protection Against Health Risks