A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

• ClinicalTrials.gov Identifier: NCT00373113
• Recruitment Status: Terminated
• First Posted: September 7, 2006
• Results First Posted: November 18, 2010
• Last Update Posted: June 25, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: September 5, 2006
• First Posted Date: September 7, 2006
• Results First Submitted Date: October 20, 2010
• Results First Posted Date: November 18, 2010
• Last Update Posted Date: June 25, 2012
• Study Start Date: November 2006
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 20, 2010)

Progression-Free Survival (PFS) [ Time Frame: From time of randomization to every 6 weeks thereafter through 22 months or until death ]

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.

• Original Primary Outcome Measures (submitted: September 5, 2006): Progression-free survival comparing Sunitinib with Capecitabine
• Change History: Complete list of historical versions of study NCT00373113 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: June 15, 2012)

• Time to Tumor Progression (TTP) [ Time Frame: From time of randomization to every 6 weeks thereafter through 22 months ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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.

• Original Secondary Outcome Measures (submitted: September 5, 2006): Time to Tumor Progression Overall Response Duration of response Overall Survival Overall survival Patient-reported outcomes Safety
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine
• Official Title: Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated
• Brief Summary: To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Neoplasms

Intervention

• Drug: Capecitabine
  1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
  Other Name: xeloda
• Drug: Sunitinib malate
  37.5 mg daily, continuous dosing
  Other Name: sunitinib

Study Arms

• Active Comparator: A
  1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
  Intervention: Drug: Capecitabine
• Experimental: B
  37.5 mg daily, continuous dosing
  Intervention: Drug: Sunitinib malate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 15, 2010): 482
• Original Enrollment (submitted: September 5, 2006): 700
• Actual Study Completion Date: June 2011
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• breast adenocarcinoma
• prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting

Exclusion Criteria:

• Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
• Any prior regimen with capecitabine

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Colombia, France, Germany, Hong Kong, India, Italy, Japan, Korea, Republic of, Mexico, Peru, Philippines, Singapore, South Africa, Spain, Taiwan, Turkey, United Kingdom

Administrative Information

• NCT Number: NCT00373113
• Other Study ID Numbers: A6181107
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2012