Phase 2b Study of Taxol Plus Sorafenib or Placebo in Patients With Advanced Breast Cancer
NCT ID: NCT00499525
Last Updated: 2019-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
180 participants
INTERVENTIONAL
2007-06-30
2022-12-31
Brief Summary
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PURPOSE: This randomized phase II trial is studying how well paclitaxel works when given together with or without sorafenib in treating patients with locally recurrent or metastatic breast cancer.
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Detailed Description
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Primary
* Compare progression-free survival of patients with locally recurrent or metastatic breast cancer treated with sorafenib tosylate and paclitaxel versus placebo and paclitaxel as first-line therapy.
Secondary
* Compare the objective response rate and duration of response in patients treated with these regimens.
* Compare the time to progression in patients treated with these regimens.
* Compare the survival of patients treated with these regimens.
* Compare the safety of patients treated with these regimens.
* Compare the change from baseline in the Functional Assessment of Cancer Therapy for Breast Cancer quality of life assessment score in patients treated with these regimens.
OUTLINE: This is a double-blind, randomized, multicenter study. Patients are stratified according to site of metastatic disease (visceral \[i.e., soft internal organs of the body, including lungs, heart, and the organs of the digestive, excretory, and reproductive systems\] vs nonvisceral \[i.e., osseous or soft tissue\] sites). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive paclitaxel IV over 1 hour once weekly for 3 weeks. Patients also receive oral sorafenib tosylate twice daily on days 1-28.
* Arm II: Patients receive paclitaxel as in arm I and oral placebo twice daily on days 1-28.
In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, and every 8 weeks for 24 weeks, and then every 12 weeks for the duration of study participation.
After completion of study therapy, patients are followed every 4 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm I
Patients receive paclitaxel IV over 1 hour once weekly for 3 weeks. Patients also receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
paclitaxel
given IV
sorafenib tosylate
given orallly
Arm II
Patients receive paclitaxel as in arm I and oral placebo twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
paclitaxel
given IV
placebo
given orally
Interventions
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paclitaxel
given IV
sorafenib tosylate
given orallly
placebo
given orally
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed adenocarcinoma of the breast
* Locally recurrent or metastatic disease
* Locally recurrent disease not amenable to resection with curative intent
* Measurable or evaluable disease
* No HER-2 overexpression (defined as positive for gene amplification by FISH or 3+ overexpression by IHC)
* No unknown HER-2 status
* No active brain metastases
* Patients with neurological symptoms and known brain metastases treated with definitive therapy must undergo contrast CT scan or brain MRI to exclude active brain metastasis
* Previously treated brain metastases allowed provided at least 3 months since prior definitive therapy (including steroids) AND no evidence of disease
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Male or female
* Menopausal status not specified
* ECOG performance status 0-1
* Not pregnant or nursing for ≥ 2 weeks after completion of study therapy
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 2 weeks after completion of study therapy
* Hemoglobin ≥ 9.0 g/dL
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
* ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)
* INR ≤ 1.5 and aPTT within normal limits
* Anticoagulation therapy (e.g., warfarin or heparin) allowed
* Stable INR required for patients on warfarin
* Creatinine ≤ 1.5 times the ULN
* Able to swallow and retain oral medication
* More than 4 weeks since prior significant traumatic injury
* No evidence or history of bleeding diathesis or coagulopathy
* No serious nonhealing wound, ulcer, or bone fracture
* No substance abuse or medical, psychological, or social condition that would interfere with study participation or evaluation of study results
* No pre-existing peripheral neuropathy ≥ grade 2
* No clinically significant cardiac disease, including any of the following:
* New York Heart Association class II-IV congestive heart failure
* Unstable angina (i.e., angina symptoms at rest) or new-onset angina within the past 3 months
* Myocardial infarction within the past 6 months
* No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 90 mm Hg despite optimal medical management)
* No thrombolic, embolic, venous, or arterial events such as a cerebrovascular accident, including transient ischemic attacks within the past 6 months
* No pulmonary hemorrhage or bleeding event \> grade 2 within the past 4 weeks
* No other hemorrhage or bleeding event ≥ grade 3 within the past 4 weeks
* No active clinically serious infection \> grade 2
* No known HIV infection or chronic hepatitis B or C
* No other prior or concurrent cancer except carcinoma in situ of the cervix, treated basal cell skin cancer, superficial bladder tumors (e.g., Ta and Tis), or any cancer curatively treated for \> 5 years
* No known or suspected allergy to sorafenib tosylate or hypersensitivity to paclitaxel or drugs using the vehicle Cremophor
PRIOR CONCURRENT THERAPY:
* More than 12 months since prior adjuvant or neoadjuvant taxane therapy
* At least 3 weeks since other prior adjuvant chemotherapy
* At least 3 weeks since prior hormonal therapy for locally recurrent or metastatic disease
* No prior chemotherapy for locally recurrent or metastatic breast cancer
* More than 4 weeks since prior major surgery or open biopsy
* At least 3 weeks since prior radiotherapy
* Previously irradiated area must not be the only site of disease
* More than 30 days or 5 half-lives, whichever is longer, since prior investigational drug
* No prior or concurrent bevacizumab or any other licensed or investigational drugs that target VEGF or VEGF-receptor
* More than 3 weeks since prior and no concurrent Hypericum perforatum (St. John's wort ) or rifampin (rifampicin)
* No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
* No concurrent irinotecan hydrochloride or doxorubicin hydrochloride
* No other concurrent anticancer therapy (i.e., chemotherapy, radiotherapy, surgery, immunotherapy, biologic therapy, or tumor embolization)
* No concurrent nonconventional therapies (e.g., herbal)
* No concurrent palliative radiotherapy
18 Years
120 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Northwestern University
OTHER
Responsible Party
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Principal Investigators
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William J. Gradishar, MD
Role: STUDY_CHAIR
Robert H. Lurie Cancer Center
Locations
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Northwest Alabama Cancer Center, PC - Muscle Shoals
Muscle Shoals, Alabama, United States
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States
Pacific Cancer Medical Center, Incorporated
Anaheim, California, United States
Pacific Coast Hematology/Oncology Medical Group, Incorporated
Fountain Valley, California, United States
Desert Hematology-Oncology Medical Group, Incorporated
Rancho Mirage, California, United States
Sutter Cancer Center
Sacramento, California, United States
Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital
Soquel, California, United States
St. Helena, California, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Medical Oncology and Hematology, PC at Harold Leever Cancer Center
Waterbury, Connecticut, United States
George Washington University Cancer Institute
Washington D.C., District of Columbia, United States
Pasco Hernando Oncology Associates, PA - Brooksville
Brooksville, Florida, United States
Pasco Hernando Oncology Associates, PA - New Port Richey
New Port Richey, Florida, United States
Northeast Georgia Cancer Care, LLC - Medical Oncology
Athens, Georgia, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States
Hematology-Oncology Associates of Illinois
Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Cancer Institute at Alexian Brothers
Elk Grove Village, Illinois, United States
Medical and Surgical Specialists, LLC
Galesburg, Illinois, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States
Kellogg Cancer Care Center
Oak Park, Illinois, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center
Skokie, Illinois, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Family Medicine of Vincennes Clinical Trial Center
Vincennes, Indiana, United States
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Columbia, Missouri, United States
Nebraska Hematology-Oncology, PC
Lincoln, Nebraska, United States
Essex Oncology of North Jersey
Belleville, New Jersey, United States
Sussex County Medical Associates - Sparta
Sparta, New Jersey, United States
Piedmont Hematology-Oncology Associates
Winston-Salem, North Carolina, United States
Tri-County Hematology/Oncology Associates, Incorporated
Canton, Ohio, United States
Hematology Oncology Consultants, Incorporated
Columbus, Ohio, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States
Hematology and Oncology Associates of Rhode Island
Cranston, Rhode Island, United States
West Clinic - East Memphis
Memphis, Tennessee, United States
Patients' Comprehensive Cancer Center - Carrollton
Carrollton, Texas, United States
Oncology Consultants - Memorial City
Houston, Texas, United States
Cascade Cancer Center at Evergreen Hospital Medical Center
Kirkland, Washington, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States
Countries
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Other Identifiers
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NU 07B1
Identifier Type: OTHER
Identifier Source: secondary_id
STU00000776
Identifier Type: OTHER
Identifier Source: secondary_id
NU 07B1
Identifier Type: -
Identifier Source: org_study_id
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