Sorafenib and Paclitaxel in Treating Patients With Metastatic Breast Cancer

NCT00622466 | Terminated Phase 2 Results DMC

• 4 other identifiers: STU 082010-161ONYX-SCCC-112007-035CDR0000587470NCI-2011-02791
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: 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. 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. Giving sorafenib together with paclitaxel may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with paclitaxel and to how well it works in treating patients with metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; male breast cancer; recurrent breast cancer; HER2-negative breast cancer

Outcome Measures

Primary Outcomes (1)

• Time to Tumor Progression

  Progression-free survival was defined as the time of treatment to the earliest date of documentation of disease progression or death due to any cause. In the case of a participant started treatment. Tenth month of progression-free rate of sorafenib and paclitaxel will be compared agains the null progression free rate of 32% using normal approximation test.

  Time from first treatment to disease progression or death (up to 36 months)

Secondary Outcomes (7)

• Tumor Response Rate

  Up to 36 months

• Six-month Progression-free Survival

  6 months

• Time to Treatment Failure

  Up to 36 months

• Clinical Benefit Rate (Tumor Response and Stable Disease) at 24 Weeks

  24 weeks

• Duration of Response

  Up to 36 months

Study Arms (1)

Sorfenib + Paclitaxel

EXPERIMENTAL

Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15

Drug: paclitaxel; Drug: sorafenib tosylate

Interventions

paclitaxel DRUG

The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma

Also known as: Taxol, Abraxane, Onxol

Sorfenib + Paclitaxel

sorafenib tosylate DRUG

Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma

Also known as: Nexavar

Sorfenib + Paclitaxel

Eligibility Criteria

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

You may qualify if:

• Histologically\* confirmed breast cancer
• Stage IV (metastatic) disease
• Radiographic evidence of metastases NOTE: \*Histological confirmation of the actual metastasis is not required.
• Measurable disease by RECIST criteria defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (i.e., physical examination, CT scan, MRI, or x-ray) or ≥ 10 mm by spiral CT scan
• No prior radiotherapy unless growth has been documented following radiotherapy
• Primary tumor or metastatic tumor HER2-negative, defined as the following:
• Immunohistochemistry of 0 or 1+ OR the equivalent, if an automated quantitative assay is used
• HER2 fluorescent in situ hybridization (FISH) assay negative as defined by a HER2:chromosome 17 centromeric probe ratio \< 1.8 (or \< 2.2 if immunohistochemistry is less than 3+ or equivalent) OR equivalent values for negative FISH assays that do not normalize to chromosome 17
• Hormone-receptor positive (estrogen receptor-\[ER\] or progesterone receptor \[PgR\]-positive) disease or hormone receptor-negative (ER- or PgR-negative) disease
• Tumor block from initial breast cancer primary or a biopsy of a metastatic site must be available for correlative studies
• Brain metastases allowed provided the patient is stable after completion of treatment (i.e., surgery and/or radiotherapy), asymptomatic, and off steroids with 2 consecutive stable brain scans at least 4 weeks after radiotherapy

You may not qualify if:

• Bone-only or other nonmeasurable-only disease
• Newly diagnosed brain metastases
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-1
• Life expectancy \> 6 months
• Menopausal status not specified
• WBC ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcL
• Platelets ≥ 100,000/mcL
• Total bilirubin \< 1.5 times upper limit of normal (ULN)
• AST and ALT transaminases ≤ 2.5 times ULN (\< 5 times ULN if liver involvement)
• Creatinine \< 1.5 times ULN OR creatinine clearance \> 60 mL/min
• INR \< 1.5 OR PT/PTT normal
• Not pregnant or nursing
• Negative pregnancy test

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Paclitaxel; Albumin-Bound 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; 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

Results Point of Contact

• Title: Dr. Barbara Haley
• Organization: The University of Texas Southwestern Medical Center

barbara.haley@utsouthwestern.edu

214-648-4180

Study Officials

• Barbara B. Haley, MD

  Simmons Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: February 25, 2008
• Study Start: April 23, 2008
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Locations

US (1)