Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00373113
First received: September 5, 2006
Last updated: June 15, 2012
Last verified: June 2012

September 5, 2006
June 15, 2012
November 2006
October 2009   (final data collection date for primary outcome measure)
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.
Progression-free survival comparing Sunitinib with Capecitabine
Complete list of historical versions of study NCT00373113 on ClinicalTrials.gov Archive Site
  • 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.

Time to Tumor Progression Overall Response Duration of response Overall Survival Overall survival Patient-reported outcomes Safety
Not Provided
Not Provided
 
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasms
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
482
June 2011
October 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT00373113
A6181107
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

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