Docetaxel With Bevacizumab as First-Line Therapy in Treating Women With Stage IV Breast Cancer

NCT00217672 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000442877UCLA-0501049-01TORI-B-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether giving docetaxel together with bevacizumab is more effective than docetaxel alone in treating breast cancer. PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with bevacizumab works compared to docetaxel alone as first-line therapy in treating women with stage IV breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• Antitumor Activity Based on Time to Tumor Progression (TTP).

  From randomization until tumor progression

Secondary Outcomes (2)

• Comparison of Response Rates, Duration of Response, and Overall Survival

  Time of death, up to 3 years

• Comparison of Safety and Toxicity

  When adverse events occur, up to 30 days after last dose for each subject, up to 3 years from start of study

Study Arms (2)

Bevacizumab + Docetaxel

EXPERIMENTAL

docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent. Bevacizumab: 15 mg/kg IV every 3 weeks. Subjects continue on study until disease progression, unacceptable toxicity, or withdrawal of patient consent.

Biological: bevacizumab; Drug: Docetaxel

docetaxel

ACTIVE COMPARATOR

docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.

Drug: Docetaxel

Interventions

bevacizumab BIOLOGICAL

Patients receive bevacizumab 15 mg/kg intravenously (I.V.) every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal.

Bevacizumab + Docetaxel

Docetaxel DRUG

docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.

Bevacizumab + Docetaxel; docetaxel

Eligibility Criteria

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

You may qualify if:

• Female 18 and over
• Histologically or cytologically confirmed adenocarcinoma of the breast at first diagnosis
• Stage IV disease, with at least one measurable lesion according to the RECIST criteria.
• HER2-negative disease, by fluorescence in situ hybridization
• ECOG performance status 0-1
• Life expectancy of at least 24 weeks
• No prior chemotherapy for metastatic breast cancer (prior endocrine therapy is permitted).
• Prior adjuvant chemotherapy is permitted. If patients received a taxane in the adjuvant setting, at least 12 months must have elapsed since the completion of adjuvant therapy.
• At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or experimental drug therapy, with complete recovery from the effects of these interventions
• If female of childbearing potential, pregnancy test is negative and willing to use effective contraception while on treatment for at least 3 months thereafter.
• Patient is accessible and willing to comply with treatment and follow-up.
• Patient is willing to provide written informed consent prior to the performance of any study-related procedures.
• Required laboratory values
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3

You may not qualify if:

• Prior chemotherapy for metastatic breast cancer
• Prior treatment with an anti-angiogenic agent
• Concurrent therapy with any other non-protocol anti-cancer therapy
• Current or prior history of central nervous system or brain metastases
• Presence of neuropathy \> grade 2 (NCI- Common Toxicity Criteria (CTC) version 3.0) at baseline
• Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (\> grade 2) peripheral vascular disease
• History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix
• Clinically significant cardiovascular disease (e.g., uncontrolled hypertension \[BP \> 150/100\]), myocardial infarction or stroke within the past 6 months, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
• Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning therapy
• Active, uncontrolled infection requiring parenteral antimicrobials
• The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications.
• Inability to comply with the study protocol or follow-up procedures
• Pregnancy or lactation
• A history of a severe hypersensitivity reaction to Bevacizumab, or Docetaxel or other drugs formulated with polysorbate 80.
• Evidence of bleeding diathesis or coagulopathy

Sponsors & Collaborators

• Translational Oncology Research International: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

Small sample size and that it was changed from a 2-arm study to a single arm study. This was necessary with public release of E2100 results(improved progression free survival) and subsequent availability of bevacizumab outside of clinical trial.

Results Point of Contact

• Title: Sara Hurvitz, M.D.
• Organization: University of California, Los Angeles

shurvitz@mednet.ucla.edu

310-829-5471

Study Officials

• Sara Hurvitz, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: May 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: November 1, 2010
• Last Updated: August 5, 2020
• Results First Posted: March 29, 2016

Record last verified: 2016-02

Locations

US (1)