A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

• Progression-Free Survival (PFS) [ Time Frame: From time of randomization to every 6 weeks thereafter through 22 months or until death ] [ Designated as safety issue: No ]
  Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.
  
  

• Time to Tumor Progression (TTP) [ Time Frame: From time of randomization to every 6 weeks thereafter through 22 months ] [ Designated as safety issue: No ]
  Time from randomization to first documentation of objective tumor progression.
  
  
• Number of Participants With Overall Response (OR) [ Time Frame: From time of randomization to every 6 weeks thereafter through 22 months ] [ Designated as safety issue: No ]
  OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
  
  
• Duration of Response (DR) [ Time Frame: From time of randomization to every 6 weeks thereafter through 22 months or death ] [ Designated as safety issue: No ]
  Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
  
  
• Time to Tumor Response (TTR) [ Time Frame: From time of randomization to every 6 weeks thereafter through 22 months ] [ Designated as safety issue: No ]
  Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
  
  
• Overall Survival (OS) [ Time Frame: From time of randomization until death ] [ Designated as safety issue: No ]
  Average time from randomization to first documentation of death due to any cause.
  
  
• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: From Day 1 of Cycle 1, then odd numbered cycles thereafter ] [ Designated as safety issue: No ]

  EORTC QLQ-C30 scales: functional (physical/role/cognitive/emotional/social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea).

  Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.

  
  
• EORTC QLQ Breast Cancer Module (BR23) [ Time Frame: From Day 1 of Cycle 1, then odd numbered cycles thereafter ] [ Designated as safety issue: No ]

  BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much.

  Scale score range: 0 to 100. Higher symptom score implied a greater degree of symptoms.

  
  

Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25Mar2009. Patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy. There were no safety concerns leading to the decision to terminate the study.