Clinical trial NCT00662025: Study Of Sunitinib With Capecitabine In Breast Cancer
Official title: A Phase II Study Of Sunitinib Malate In Combination With Capecitabine In Patients With Advanced Or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced/Metastatic Breast Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 63
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of Participants With Objective Response Based on Data Review Committee's Assessment
timeFrame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.
Secondary outcomes:
measure: Number of Participants With Objective Response Based on Investigator's Assessment
timeFrame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.
measure: Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment
timeFrame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.
measure: Number of Subjects With CBR Based on Investigator's Assessment
timeFrame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.
measure: Progression-Free Survival (PFS)
timeFrame: 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.
measure: Time to Tumor Progression (TTP)
timeFrame: 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.
measure: Duration of Objective Tumor Response (DR)
timeFrame: 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.
measure: Time to Objective Tumor Response (TTR)
timeFrame: 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.
measure: Overall Survival (OS)
timeFrame: A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study.
measure: Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
timeFrame: Days 14 and 15 of Cycle 1
measure: Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
timeFrame: Days 14 and 15 of Cycle 1
measure: Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
timeFrame: Days 14 and 15 of Cycle 1
measure: AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
timeFrame: Days 14 and 15 of Cycle 1
measure: Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
timeFrame: Day 14 of Cycle 1
measure: Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
timeFrame: Day 14 of Cycle 1
measure: AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
timeFrame: Day 14 of Cycle 1
measure: t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
timeFrame: Day 14 of Cycle 1
Other outcomes:
Locations:
city: Anjo-city
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Okazaki-City
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Toyoake
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Matsuyama-shi
country: Japan
facility: Pfizer Investigational Site
state: Ehime
city: Kure
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Morioka
country: Japan
facility: Pfizer Investigational Site
state: Iwate
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Sakai
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chiba
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Kagoshima
country: Japan
facility: Pfizer Investigational Site
city: Kyoto
country: Japan
facility: Pfizer Investigational Site
city: Niigata
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: