A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

A Phase 3 Study Of SU011248 In Combination With Paclitaxel Versus Bevacizumab With Paclitaxel In The First-Line Advanced Disease Setting In Patients Having Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373256
• Other study ID #: A6181094
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2006
• Last updated: September 5, 2012
• Start date: November 2006
• Est. completion date: August 2011

Study information

• Verified date: September 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer

Description:

On May 27, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181094. The DMC determined Study A6181094 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus paclitaxel versus bevacizumab plus paclitaxel. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Enrollment in this study has been stopped.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: August 2011
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of advanced breast cancer.

• Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.

• ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

Exclusion Criteria:

• No prior treatment with cytotoxics in the advanced disease setting.

• HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.

• Treatment with a taxane in the adjuvant setting unless disease free interval >12 months after end of treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Sunitinib
Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,
• paclitaxel
Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.
• bevacizumab
Bevacizumab 10 mg/kg IV every 2 weeks.
• paclitaxel
Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Trier
Italy	Pfizer Investigational Site	Cremona
Italy	Pfizer Investigational Site	Grosseto
Italy	Pfizer Investigational Site	Olbia
Spain	Pfizer Investigational Site	Cabueñes	Gijon
Spain	Pfizer Investigational Site	Guadalajara
Spain	Pfizer Investigational Site	Madrid
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Allentown	Pennsylvania
United States	Pfizer Investigational Site	Amarillo	Texas
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Annapolis	Maryland
United States	Pfizer Investigational Site	Antioch	California
United States	Pfizer Investigational Site	Antioch	California
United States	Pfizer Investigational Site	Antonio	Texas
United States	Pfizer Investigational Site	Arlington	Virginia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Avon	Indiana
United States	Pfizer Investigational Site	Baldwin Park	California
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bedford	Texas
United States	Pfizer Investigational Site	Beech Grove	Indiana
United States	Pfizer Investigational Site	Bellflower	California
United States	Pfizer Investigational Site	Bessemer	Alabama
United States	Pfizer Investigational Site	Bethlehem	Pennsylvania
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Boca Raton	Florida
United States	Pfizer Investigational Site	Boulder	Colorado
United States	Pfizer Investigational Site	Bristol	Tennessee
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Burlington	Massachusetts
United States	Pfizer Investigational Site	Canton	Ohio
United States	Pfizer Investigational Site	Carmel	Indiana
United States	Pfizer Investigational Site	Cary	North Carolina
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Christiansburg	Virginia
United States	Pfizer Investigational Site	Clinton	North Carolina
United States	Pfizer Investigational Site	Colorado Springs	Colorado
United States	Pfizer Investigational Site	Colorado Springs	Colorado
United States	Pfizer Investigational Site	Columbia	Maryland
United States	Pfizer Investigational Site	Columbia	Missouri
United States	Pfizer Investigational Site	Columbus	Georgia
United States	Pfizer Investigational Site	Columbus	Georgia
United States	Pfizer Investigational Site	Coon Rapids	Minnesota
United States	Pfizer Investigational Site	Coral Springs	Florida
United States	Pfizer Investigational Site	Corning	New York
United States	Pfizer Investigational Site	Corpus Christi	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Daphne	Alabama
United States	Pfizer Investigational Site	Davie	Florida
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Dover	Ohio
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Easley	South Carolina
United States	Pfizer Investigational Site	Ephrata	Pennsylvania
United States	Pfizer Investigational Site	Eugene	Oregon
United States	Pfizer Investigational Site	Fairfax	Virginia
United States	Pfizer Investigational Site	Federal Way	Washington
United States	Pfizer Investigational Site	Fishers	Indiana
United States	Pfizer Investigational Site	Flagstaff	Arizona
United States	Pfizer Investigational Site	Fontana	California
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Forth Worth	Texas
United States	Pfizer Investigational Site	Fountain Valley	California
United States	Pfizer Investigational Site	Fremont	Nebraska
United States	Pfizer Investigational Site	Gilroy	California
United States	Pfizer Investigational Site	Goldsboro	North Carolina
United States	Pfizer Investigational Site	Grand Island	Nebraska
United States	Pfizer Investigational Site	Greenfield	Indiana
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Harvey	Illinois
United States	Pfizer Investigational Site	Hawthorne	California
United States	Pfizer Investigational Site	Hayward	California
United States	Pfizer Investigational Site	Henderson	Nevada
United States	Pfizer Investigational Site	Henderson	Nevada
United States	Pfizer Investigational Site	Hershey	Pennsylvania
United States	Pfizer Investigational Site	Hickory	North Carolina
United States	Pfizer Investigational Site	Hollywood	Florida
United States	Pfizer Investigational Site	Hot Springs	Arkansas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Huntington	West Virginia
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Inverness	Florida
United States	Pfizer Investigational Site	Irvine	California
United States	Pfizer Investigational Site	Jamaica	New York
United States	Pfizer Investigational Site	Jeffersonville	Indiana
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kansas City	Kansas
United States	Pfizer Investigational Site	Kenansville	North Carolina
United States	Pfizer Investigational Site	Kennewick	Washington
United States	Pfizer Investigational Site	Kerrville	Texas
United States	Pfizer Investigational Site	Kingsport	Tennessee
United States	Pfizer Investigational Site	Kingston	Pennsylvania
United States	Pfizer Investigational Site	Kinston	North Carolina
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	Lakeland	Florida
United States	Pfizer Investigational Site	Lakewood	Colorado
United States	Pfizer Investigational Site	Lakewood	Washington
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Lee's Summit	Missouri
United States	Pfizer Investigational Site	Leesburg	Virginia
United States	Pfizer Investigational Site	Lenoir	North Carolina
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Littleton	Colorado
United States	Pfizer Investigational Site	Lone Tree	Colorado
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Longmont	Colorado
United States	Pfizer Investigational Site	Longview	Texas
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Macon	Georgia
United States	Pfizer Investigational Site	Marietta	Georgia
United States	Pfizer Investigational Site	Martinez	California
United States	Pfizer Investigational Site	Melbourne	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Midland	Texas
United States	Pfizer Investigational Site	Milpitas	California
United States	Pfizer Investigational Site	Mineola	New York
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Modesto	California
United States	Pfizer Investigational Site	Mooresville	Indiana
United States	Pfizer Investigational Site	Morgantown	West Virginia
United States	Pfizer Investigational Site	Moses Lake	Washington
United States	Pfizer Investigational Site	Mountain View	California
United States	Pfizer Investigational Site	Munster	Indiana
United States	Pfizer Investigational Site	New Albany	Indiana
United States	Pfizer Investigational Site	Norton	Virginia
United States	Pfizer Investigational Site	Norwalk	Connecticut
United States	Pfizer Investigational Site	Oakland	California
United States	Pfizer Investigational Site	Ocean Springs	Mississippi
United States	Pfizer Investigational Site	Ogden	Utah
United States	Pfizer Investigational Site	Ontario	California
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Oxnard	California
United States	Pfizer Investigational Site	Panorama City	California
United States	Pfizer Investigational Site	Parker	Colorado
United States	Pfizer Investigational Site	Pascagoula	Mississippi
United States	Pfizer Investigational Site	Peabody	Massachusetts
United States	Pfizer Investigational Site	Pembroke Pines	Florida
United States	Pfizer Investigational Site	Pinole	California
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Pollocksville	North Carolina
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Puyallup	Washington
United States	Pfizer Investigational Site	Raleight	North Carolina
United States	Pfizer Investigational Site	Raliegh	North Carolina
United States	Pfizer Investigational Site	Randallstown	Maryland
United States	Pfizer Investigational Site	Richlands	North Carolina
United States	Pfizer Investigational Site	Riverside	California
United States	Pfizer Investigational Site	Roanoke	Virginia
United States	Pfizer Investigational Site	Robbinsdale	Minnesota
United States	Pfizer Investigational Site	Round Rock	Texas
United States	Pfizer Investigational Site	Round Rock	Texas
United States	Pfizer Investigational Site	Round Rock	Texas
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Salem	Virginia
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	San Jose	California
United States	Pfizer Investigational Site	San Marcos	Texas
United States	Pfizer Investigational Site	San Sacramento	California
United States	Pfizer Investigational Site	Santa Clara	California
United States	Pfizer Investigational Site	Santa Monica	California
United States	Pfizer Investigational Site	Sayre	Pennsylvania
United States	Pfizer Investigational Site	Sedona	Arizona
United States	Pfizer Investigational Site	Seneca	South Carolina
United States	Pfizer Investigational Site	Shenandoah	Texas
United States	Pfizer Investigational Site	Skokie	Illinois
United States	Pfizer Investigational Site	Spartanburg	South Carolina
United States	Pfizer Investigational Site	Springfield	Oregon
United States	Pfizer Investigational Site	Tacoma	Washington
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Thornton	Colorado
United States	Pfizer Investigational Site	Tinley Park	Illinois
United States	Pfizer Investigational Site	Tualatin	Oregon
United States	Pfizer Investigational Site	Tyler	Texas
United States	Pfizer Investigational Site	Union City	California
United States	Pfizer Investigational Site	Vallejo	California
United States	Pfizer Investigational Site	Vancouver	Washington
United States	Pfizer Investigational Site	Vancouver	Washington
United States	Pfizer Investigational Site	Vernon Hills	Illinois
United States	Pfizer Investigational Site	Waco	Texas
United States	Pfizer Investigational Site	Walnut Creek	California
United States	Pfizer Investigational Site	Washington	North Carolina
United States	Pfizer Investigational Site	Wenatchee	Washington
United States	Pfizer Investigational Site	Wilson	North Carolina
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
United States	Pfizer Investigational Site	Winter Park	Florida
United States	Pfizer Investigational Site	Woodbridge	Virginia
United States	Pfizer Investigational Site	Woodland Hills	California
United States	Pfizer Investigational Site	Wytheville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4	From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death	No
Secondary	Number of Participants With Objective Response	Objective response = participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.	From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months	No
Secondary	Duration of Response (DR)	DR=time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. DR was calculated as [the date response ended (ie, date of progressive disease or death) minus first CR or PR date that was subsequently confirmed +1)] divided by 30.4.	From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause	No
Secondary	Overall Survival (OS)	OS was defined as the time from date of randomization to death due to any cause. OS (in months) was calculated as (date of death minus randomization date +1) divided by 30.4.	From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.	No
Secondary	Percentage of Participants Surviving at 1 and 2 Years	Percentage of those surviving at the end of one year or end of 2 years from the first dose of study treatment.	Year 1, Year 2	No
Secondary	European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)	EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.	Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months	No
Secondary	EORTC QLQ Breast Cancer Module (BR23)	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 = greater degree of symptoms.	Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months	No
Secondary	Euro Quality of Life-5 Dimension (EQ-5D)	EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the subject.	Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months	No
Secondary	EQ - Visual Analog Scale (EQ-VAS)	EQ-VAS score on the self-rated "thermometer," indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.	Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months	No
Secondary	Biomarkers	Concentrations of plasma proteins (eg, soluble Vascular Endothelial Growth Factor Receptor 2 [VEGFR2] and VEGFR3, VEGF-A, placental growth factor [PlGF], soluble KIT, and possibly soluble PDGFRß and PDGF) that may be associated with angiogenesis and tumor proliferation.	Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1	No

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