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A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

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

Tracking Information
First Submitted Date  ICMJE September 5, 2006
First Posted Date  ICMJE September 7, 2006
Results First Submitted Date  ICMJE October 20, 2010
Results First Posted Date  ICMJE November 18, 2010
Last Update Posted Date June 25, 2012
Study Start Date  ICMJE November 2006
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 15, 2010)
482
Original Enrollment  ICMJE
 (submitted: September 5, 2006)
700
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00373113
Other Study ID Numbers  ICMJE A6181107
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP