Study Of Sunitinib With Capecitabine In Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00662025
First received: April 17, 2008
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.


Condition Intervention Phase
Advanced/Metastatic Breast Cancer
Drug: Capecitabine
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Sunitinib Malate In Combination With Capecitabine In Patients With Advanced Or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Objective Response Based on Data Review Committee's Assessment [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. ] [ Designated as safety issue: No ]
    Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.


Secondary Outcome Measures:
  • Number of Participants With Objective Response Based on Investigator's Assessment [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study. ] [ Designated as safety issue: No ]
    Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.

  • Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. ] [ Designated as safety issue: No ]
    Number of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.

  • Number of Subjects With CBR Based on Investigator's Assessment [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study. ] [ Designated as safety issue: No ]
    Number of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.

  • Progression-Free Survival (PFS) [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. ] [ Designated as safety issue: No ]
    Based on Data Review Committee's Assessment. PFS is defined as the time from the start of study treatment to first documentation of objective tumor progression, or to death on study due to any cause, whichever occurred first.

  • Time to Tumor Progression (TTP) [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. ] [ Designated as safety issue: No ]
    Based on Data Review Committee's Assessment. TTP is defined as the time from the start of study treatment to first documentation of objective tumor progression.

  • Duration of Objective Tumor Response (DR) [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. ] [ Designated as safety issue: No ]
    Based on Data Review Committee's Assessment. DR is defined as the time from the first documentation of objective tumor response (confirmed CR or PR) to the first documentation of disease progression or to death due to cancer, whichever occurred first. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.

  • Time to Objective Tumor Response (TTR) [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. ] [ Designated as safety issue: No ]
    Based on Data Review Committee's Assessment. TTR is defined as the time from the start of study treatment to first documentation of objective tumor response (confirmed CR or PR). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.

  • Overall Survival (OS) [ Time Frame: A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study. ] [ Designated as safety issue: No ]
    OS is defined as the time from the start of study treatment to death due to any cause. OS data is censored on the last day they were known to be alive in the absence of confirmation of death.

  • Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) [ Time Frame: Days 14 and 15 of Cycle 1 ] [ Designated as safety issue: No ]

    SU012662 is a metabolite of sunitinib. Trough plasma concentration (Ctrough) means the concentration prior to study drug administration.

    The Ctrough for total drug (sunitinib+SU012662) was calculated as the mean of the Ctrough of total drug from individual participant.


  • Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) [ Time Frame: Days 14 and 15 of Cycle 1 ] [ Designated as safety issue: No ]

    SU012662 is a metabolite of sunitinib. Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).

    The Tmax for total drug (sunitinib+SU012662) was calculated as the median of the Tmax of total drug from individual participant.


  • Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) [ Time Frame: Days 14 and 15 of Cycle 1 ] [ Designated as safety issue: No ]

    SU012662 is a metabolite of sunitinib. Cmax means a maximum observed plasma concentration.

    The Cmax for total drug (sunitinib+SU012662) was calculated as the mean of the Cmax of total drug from individual participant.


  • AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) [ Time Frame: Days 14 and 15 of Cycle 1 ] [ Designated as safety issue: No ]

    SU012662 is a metabolite of sunitinib. AUC(0-24) means an area under the plasma concentration time curve from time zero to 24 hours post-dose.

    The AUC(0-24) for total drug (sunitinib+SU012662) was calculated as the mean of the AUC(0-24) of total drug from individual participant.


  • Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) [ Time Frame: Day 14 of Cycle 1 ] [ Designated as safety issue: No ]

    Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).

    5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil


  • Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) [ Time Frame: Day 14 of Cycle 1 ] [ Designated as safety issue: No ]
    Cmax means a maximum observed plasma concentration. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil

  • AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) [ Time Frame: Day 14 of Cycle 1 ] [ Designated as safety issue: No ]

    AUC(0-inf) means an area under the plasma concentration time curve from time zero to Infinity.

    5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil


  • t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) [ Time Frame: Day 14 of Cycle 1 ] [ Designated as safety issue: No ]
    t1/2 means a terminal phase half-life. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil


Enrollment: 63
Study Start Date: April 2008
Study Completion Date: May 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Capecitabine
Capecitabine 1000 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
Drug: Sunitinib
Sunitinib 37.5 mg daily, continuous dosing

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent
  • Measurable disease as per RECIST. Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
  • Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings.

Exclusion Criteria:

  • Histology of inflammatory carcinoma with no other measurable disease. Patients with histology of inflammatory carcinoma are allowed on study if they have measurable disease.
  • Brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease.
  • Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon (5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1 (tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662025

Locations
Japan
Pfizer Investigational Site
Anjo-city, Aichi, Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Okazaki-City, Aichi, Japan
Pfizer Investigational Site
Toyoake, Aichi, Japan
Pfizer Investigational Site
Matsuyama-shi, Ehime, Japan
Pfizer Investigational Site
Kure, Hiroshima, Japan
Pfizer Investigational Site
Morioka, Iwate, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Sakai, Osaka, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Koto-ku, Tokyo, Japan
Pfizer Investigational Site
Chiba, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Kagoshima, Japan
Pfizer Investigational Site
Kyoto, Japan
Pfizer Investigational Site
Niigata, Japan
Pfizer Investigational Site
Osaka, Japan
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: NCT00662025     History of Changes
Other Study ID Numbers: A6181163
Study First Received: April 17, 2008
Results First Received: September 20, 2010
Last Updated: May 22, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on April 23, 2014