A Phase II Study Of Abraxane and Nexavar in the First-Line Treatment of Locally Advanced or Metastatic Breast Cancer

NCT00607438 | Terminated Phase 2

• 1 other identifier: I-06-025
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II, open-label, non-randomized study in patients with locally advanced or metastatic breast cancer. Each cycle will be 4 weeks in length. Patients will receive Abraxane weekly for 3 weeks. Patients will not receive Abraxane during week 4 (rest week). Nexavar will be given continuously. Patients will be radiologically evaluated every 8 weeks for response. Patients will continue to receive study treatment until disease progression or unacceptable toxicity.

Conditions

Breast Cancer

Keywords

Locally Advanced or Metastatic

Outcome Measures

Primary Outcomes (1)

• To evaluate the progression-free survival (PFS)and duration of response of the combination of weekly Abraxane and continuous Nexavar as first-line treatment for patients with locally advanced or metastatic breast cancer.

  Survival every 3 months for two years starting from the end of study date. Duration of response every 8 weeks while on treatment.

Secondary Outcomes (3)

• To evaluate the response rate.

  Every 8 weeks while on study treatment.

• Evaluate the 1 and 2 year survival rate.

  Every 3 months for 2 years starting from the end of therapy visit date

• Evaluate the toxicities of the combination of Abraxane and Nexavar

  At each clinic visit or if reported by subject.

Interventions

Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane) DRUG

125 mg/m2 Paclitaxel by 30-minute IV infusion weekly for 3 weeks.

Also known as: Abraxane

Sorafenib (Nexavar) DRUG

400 mg orally twice a day continuously (even during rest week) starting on Day 1.

Also known as: Nexavar

Eligibility Criteria

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

You may qualify if:

• Patients must have signed an IRB-approved informed consent.
• Patients must have histologically confirmed locally advanced or metastatic breast cancer.
• Patients must be HER2-negative.
• Patients must have measurable disease, as defined by the RECIST criteria.
• Patients may have received prior adjuvant chemotherapy for breast cancer, including taxane-containing regimens, provided this treatment was completed at least 12 months prior to enrollment.
• Patients must be \<18 years of age.
• Patients must have an ECOG Performance Status of 0 or 1.
• Patients' estimated life expectancy must be at least 12 weeks.
• Patients must have adequate liver functions defined as: total bilirubin within normal limits and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 X upper limit of normal (ULN) (or \< 5 X ULN for patients with liver involvement).
• Patients must have alkaline phosphatase ≤ 2.5 X ULN. Alkaline phosphatase may be \> 2.5 x ULN if bone metastasis is present in the absence of liver metastasis, and the patient's bilirubin ≤ ULN.
• Patients must have adequate renal function defined as: creatinine ≤ 1.5 mg/dL.
• Patients must have adequate bone marrow function, including absolute neutrophil count (ANC) \>1500/µL, platelet count \>100,000/µL, and hemoglobin \>9 g/dL.
• Patients must have a normal baseline left ventricular ejection fraction (LVEF).
• Patients must be normotensive. Patients taking anti-hypertensive medication must have blood pressure controlled and not greater than 140/90.
• International Normalized Ratio (INR) \< 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits.

You may not qualify if:

• Patients who have received prior chemotherapy for the treatment of locally advanced or metastatic breast cancer.
• Patients who have received prior Abraxane or Nexavar.
• Patients who have a history of hypersensitivity or a suspected allergy to taxanes, any of the components in taxanes, Abraxane, or Nexavar.
• Patients with serious intercurrent medical or psychiatric illness, including serious active infection.
• Patients with untreated or active brain metastases. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
• Patients with a history of thrombosis.
• Patients with thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• Patients with symptomatic congestive heart failure or a baseline echocardiogram with LVEF \< ULN.
• Patients with congestive heart failure \> class II New York Heart Association (NYHA). Patients must not have unstable angina (anginal symptoms at rest), or new onset angina (began within the last 3 months), or myocardial infarction within the past 6 months.
• Patients with cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Patients with a history of, or active, bowel perforation or inflammatory bowel disease.
• Patients with active peptic ulcer disease or symptoms to suggest possible ulcer (discontinuation of chronic NSAID therapy advised, or if not possible, use of proton-pump inhibitors recommended.)
• Patients planning to receive any concurrent therapy to treat locally advanced or metastatic breast cancer during the study treatment period.
• Any patient who is pregnant or lactating.
• Patients with proteinuria \> +1 by baseline dipstick, or if +2, 24-hour urine total protein \> 250 mg.

Sponsors & Collaborators

• Veeda Oncology: lead
• Bayer: collaborator
• Celgene Corporation: collaborator

Study Sites (1)

Veeda Oncology

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Albumin-Bound Paclitaxel; Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Barry Mirtsching, MD

  Veeda Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 5, 2008
• Study Start: September 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 11, 2012

Record last verified: 2012-05

Locations

US (1)