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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
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
Drug: Capecitabine
Drug: Sunitinib malate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 482
Study Start Date: November 2006
Study Completion Date: June 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Experimental: B
37.5 mg daily, continuous dosing
Drug: Sunitinib malate
37.5 mg daily, continuous dosing
Other Name: sunitinib

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373113

  Hide Study Locations
Locations
Argentina
Pfizer Investigational Site
Bahia Blanca, Prov. de Buenos Aires, Argentina, B8001HXM
Pfizer Investigational Site
Viedma, Rio Negro, Argentina, 8500
Pfizer Investigational Site
Rosario, Santa Fé, Argentina, (2000)
Pfizer Investigational Site
Buenos Aires, Argentina, C1034ACO
Pfizer Investigational Site
Buenos Aires, Argentina, C1405BCH
Pfizer Investigational Site
Cordoba, Argentina, X5000AAI
Pfizer Investigational Site
Tucuman, Argentina, T4000IAK
Australia, New South Wales
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
Pfizer Investigational Site
Herston, Queensland, Australia, 4029
Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Pfizer Investigational Site
Heidelberg, Victoria, Australia, 3084
Pfizer Investigational Site
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Pfizer Investigational Site
Perth, Western Australia, Australia, 6000
Brazil
Pfizer Investigational Site
Curitiba, PR, Brazil, 80530-010
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 20560-120
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90610-000
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 91350-200
Pfizer Investigational Site
São Paulo, SP, Brazil, 01246-000
Pfizer Investigational Site
São Paulo, SP, Brazil, 01509-900
Bulgaria
Pfizer Investigational Site
Sofia, Bulgaria, 1233
Pfizer Investigational Site
Sofia, Bulgaria, 1756
Pfizer Investigational Site
Sofia, Bulgaria, 1527
Pfizer Investigational Site
Stara Zagora, Bulgaria, 6000
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 3A7
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6A 4L6
Pfizer Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Canada
Pfizer Investigational Site
Quebec, Canada, G1S 4L8
Chile
Pfizer Investigational Site
Temuco, IX Región, Chile, 4810469
Colombia
Pfizer Investigational Site
Medellin, Antioquia, Colombia
Pfizer Investigational Site
Bogotá, Cundinamarca, Colombia
France
Pfizer Investigational Site
Bayonne, France, 64100
Pfizer Investigational Site
Besancon, France, 25030
Pfizer Investigational Site
Clermont Ferrand, France, 63011
Pfizer Investigational Site
Lille, France, 59020 Cedex
Pfizer Investigational Site
Neuilly Sur Seine, France, 92200
Pfizer Investigational Site
Nice, France, 06100
Pfizer Investigational Site
Rennes Cedex, France, 35042
Germany
Pfizer Investigational Site
Berlin, Germany, 12200
Pfizer Investigational Site
Frankfurt, Germany, 60488
Pfizer Investigational Site
Freiburg, Germany, 79106
Pfizer Investigational Site
Jena, Germany, 07743
Pfizer Investigational Site
Kiel, Germany, 24103
Pfizer Investigational Site
Leer, Germany, 26789
Pfizer Investigational Site
Luebeck, Germany, 23538
Pfizer Investigational Site
Magdeburg, Germany, 39130
Pfizer Investigational Site
Mainz, Germany, 55101
Pfizer Investigational Site
Meiningen, Germany, 98617
Pfizer Investigational Site
Muenchen, Germany, 81675
Pfizer Investigational Site
Offenburg, Germany, 77652
Pfizer Investigational Site
Tuebingen, Germany, 72076
Hong Kong
Pfizer Investigational Site
Hong Kong, Hong Kong
Pfizer Investigational Site
Kowloon, Hong Kong
Pfizer Investigational Site
Tuen Mun, Hong Kong
Pfizer Investigational Site
Wan Chai,, Hong Kong
India
Pfizer Investigational Site
Navrangpura / Ahmedabad, Gujarat, India, 380 009
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 078
Pfizer Investigational Site
Ludhiana, Punjab, India, 141 008
Pfizer Investigational Site
Jaipur, Rajasthan, India, 302013
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India, 226003
Italy
Pfizer Investigational Site
Firenze, Italy, 50134
Pfizer Investigational Site
Milano, Italy, 20162
Pfizer Investigational Site
Napoli, Italy, 80131
Pfizer Investigational Site
Reggio Emilia, Italy, 42100
Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Matsuyama-shi, Ehime, Japan
Pfizer Investigational Site
Kitakyushu-City, Fukuoka, Japan
Pfizer Investigational Site
Suita, Osaka, Japan
Pfizer Investigational Site
Kita-adachi-gun, Saitama, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Chuo-Ku, Tokyo, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Osaka, Japan
Korea, Republic of
Pfizer Investigational Site
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Pfizer Investigational Site
Daegu, Korea, Republic of, 705-717
Pfizer Investigational Site
Incheon, Korea, Republic of, 400-711
Pfizer Investigational Site
Pusan, Korea, Republic of, 602-739
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Mexico
Pfizer Investigational Site
Mexico, DF, Mexico, 11000
Pfizer Investigational Site
Toluca, Estado de Mexico, Mexico, 50180
Pfizer Investigational Site
Acapulco, Guerrero, Mexico, 39670
Pfizer Investigational Site
Morelia, Michoacan, Mexico, 58020
Pfizer Investigational Site
Ciudad Obregon, Sonora, Mexico, 85000
Pfizer Investigational Site
Chihuahua, Mexico, 31000
Pfizer Investigational Site
Puebla, Mexico, 72530
Peru
Pfizer Investigational Site
Lima, Peru, L 27
Pfizer Investigational Site
Lima, Peru, 05127
Philippines
Pfizer Investigational Site
Quezon City, Philippines, 1100
Pfizer Investigational Site
Quezon City, Philippines, 1102
Pfizer Investigational Site
Quezon City, Philippines, 1104
Pfizer Investigational Site
San Juan City, Philippines, 1000
Singapore
Pfizer Investigational Site
Singapore, Singapore, 169610
Pfizer Investigational Site
Singapore, Singapore, 119074
South Africa
Pfizer Investigational Site
Parktown, South Africa, 2193
Pfizer Investigational Site
Sandton, South Africa, 2199
Spain
Pfizer Investigational Site
Mataro, Barcelona, Spain, 08304
Pfizer Investigational Site
Sabadell, Barcelona, Spain, 08208
Pfizer Investigational Site
Santander, Cantabria, Spain, 39008
Pfizer Investigational Site
Alcorcon, Madrid, Spain, 28922
Pfizer Investigational Site
Bilbao, Vizcaya, Spain, 48013
Pfizer Investigational Site
Cordoba, Spain, 14004
Pfizer Investigational Site
Gerona, Spain, 17007
Pfizer Investigational Site
Jaen, Spain, 23007
Pfizer Investigational Site
La Coruña, Spain, 15006
Pfizer Investigational Site
Las Palmas de Gran Canaria, Spain, 35016
Pfizer Investigational Site
Madrid, Spain, 28033
Pfizer Investigational Site
Madrid, Spain, 28040
Pfizer Investigational Site
Malaga, Spain, 29010
Pfizer Investigational Site
Salamanca, Spain, 37007
Taiwan
Pfizer Investigational Site
Changhua, Taiwan, 500
Pfizer Investigational Site
Kaohsiung, Taiwan, 807
Pfizer Investigational Site
Tainan, Taiwan, 704
Pfizer Investigational Site
Taipei, Taiwan, 112
Pfizer Investigational Site
Taipei, Taiwan, 106
Pfizer Investigational Site
Taipei, Taiwan, 100
Pfizer Investigational Site
Taoyuan, Taiwan, 333
Turkey
Pfizer Investigational Site
Ankara, Turkey, 06100
Pfizer Investigational Site
Istanbul, Turkey, 34390
United Kingdom
Pfizer Investigational Site
Cardiff, South Wales, United Kingdom, CF14 2TL
Pfizer Investigational Site
London, United Kingdom, SE1 9RT
Pfizer Investigational Site
Nottingham, United Kingdom, NG5 1PB
Pfizer Investigational Site
Somerset, United Kingdom, BA21 4AT
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00373113     History of Changes
Other Study ID Numbers: A6181107
Study First Received: September 5, 2006
Results First Received: October 20, 2010
Last Updated: June 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
advanced breast cancer
metastatic breast cancer
treatment resistant
treatment failure

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014