Phase 2b Study of Taxol Plus Sorafenib or Placebo in Patients With Advanced Breast Cancer

NCT00499525 | Unknown Phase 2 DMC

• 2 other identifiers: NU 07B1STU00000776
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 43

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving paclitaxel together with sorafenib may kill more tumor cells. 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.

Conditions

Breast Cancer

Keywords

male breast cancer; recurrent breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  At disease progression or death

Secondary Outcomes (5)

• Overall survival

  At time of death

• Time to progression

  At time of disease progression

• Overall response rate

  At the time of progression of disease

• Duration of overall response

  At time of disease progression

• Treatment-emergent adverse events as assessed by NCI CTCAE v3.0

  During treatment and up to 30 days post-treatment

Study Arms (2)

Arm I

EXPERIMENTAL

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.

Drug: paclitaxel; Drug: sorafenib tosylate

Arm II

ACTIVE COMPARATOR

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.

Drug: paclitaxel; Other: placebo

Interventions

paclitaxel DRUG

given IV

Arm I; Arm II

sorafenib tosylate DRUG

given orallly

Arm I

placebo OTHER

given orally

Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• Amgen: collaborator

Study Sites (43)

Northwest Alabama Cancer Center, PC - Muscle Shoals

Muscle Shoals, Alabama, 35661, United States

Location

Highlands Oncology Group - Fayetteville

Fayetteville, Arkansas, 72703, United States

Location

Pacific Cancer Medical Center, Incorporated

Anaheim, California, 92801, United States

Location

Pacific Coast Hematology/Oncology Medical Group, Incorporated

Fountain Valley, California, 92708, United States

Location

Desert Hematology-Oncology Medical Group, Incorporated

Rancho Mirage, California, 92270, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital

Soquel, California, 95073, United States

Location

Unknown Facility

St. Helena, California, 94574, United States

Location

Helen and Harry Gray Cancer Center at Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Medical Oncology and Hematology, PC at Harold Leever Cancer Center

Waterbury, Connecticut, 06708, United States

Location

George Washington University Cancer Institute

Washington D.C., District of Columbia, 20037, United States

Location

Pasco Hernando Oncology Associates, PA - Brooksville

Brooksville, Florida, 34613, United States

Location

Pasco Hernando Oncology Associates, PA - New Port Richey

New Port Richey, Florida, 34652, United States

Location

Northeast Georgia Cancer Care, LLC - Medical Oncology

Athens, Georgia, 30607, United States

Location

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, 83712, United States

Location

Hematology-Oncology Associates of Illinois

Chicago, Illinois, 60611-2998, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Cancer Institute at Alexian Brothers

Elk Grove Village, Illinois, 60007-3397, United States

Location

Medical and Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

Midwest Center for Hematology/Oncology

Joliet, Illinois, 60432, United States

Location

Kellogg Cancer Care Center

Oak Park, Illinois, 60302, United States

Location

Hematology/Oncology of the North Shore at Gross Point Medical Center

Skokie, Illinois, 60076, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46885-5099, United States

Location

Family Medicine of Vincennes Clinical Trial Center

Vincennes, Indiana, 47591, United States

Location

Kentuckiana Cancer Institute, PLLC

Louisville, Kentucky, 40202, United States

Location

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, 70809-3482, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Columbia, Missouri, 65201, United States

Location

Nebraska Hematology-Oncology, PC

Lincoln, Nebraska, 68510-2482, United States

Location

Essex Oncology of North Jersey

Belleville, New Jersey, 07109, United States

Location

Sussex County Medical Associates - Sparta

Sparta, New Jersey, 07871, United States

Location

Piedmont Hematology-Oncology Associates

Winston-Salem, North Carolina, 27103, United States

Location

Tri-County Hematology/Oncology Associates, Incorporated

Canton, Ohio, 44718, United States

Location

Hematology Oncology Consultants, Incorporated

Columbus, Ohio, 43235, United States

Location

North Coast Cancer Care, Incorporated

Sandusky, Ohio, 44870, United States

Location

Hematology and Oncology Associates of Rhode Island

Cranston, Rhode Island, 02920, United States

Location

West Clinic - East Memphis

Memphis, Tennessee, 38120, United States

Location

Patients' Comprehensive Cancer Center - Carrollton

Carrollton, Texas, 75010-4602, United States

Location

Oncology Consultants - Memorial City

Houston, Texas, 77024, United States

Location

Cascade Cancer Center at Evergreen Hospital Medical Center

Kirkland, Washington, 98034-3013, United States

Location

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Paclitaxel; Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• William J. Gradishar, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: May 3, 2019

Record last verified: 2019-04

Locations

US (43)