Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of California, Los Angeles
Information provided by (Responsible Party):
Translational Oncology Research International
ClinicalTrials.gov Identifier:
NCT00217672
First received: September 20, 2005
Last updated: February 25, 2016
Last verified: February 2016
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Biological: bevacizumab
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Docetaxel With or Without Bevacizumab as First-Line Therapy for Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Translational Oncology Research International:

Primary Outcome Measures:
  • Antitumor Activity Based on Time to Tumor Progression (TTP). [ Time Frame: From randomization until tumor progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of Response Rates, Duration of Response, and Overall Survival [ Time Frame: Time of death, up to 3 years ] [ Designated as safety issue: No ]
  • Comparison of Safety and Toxicity [ Time Frame: When adverse events occur, up to 30 days after last dose for each subject, up to 3 years from start of study ] [ Designated as safety issue: Yes ]
    Evaluated using adverse event (AE) information. Detailed AE information is provided in the AE section.


Enrollment: 76
Study Start Date: May 2005
Study Completion Date: November 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab + Docetaxel

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
Patients receive bevacizumab 15 mg/kg intravenously (I.V.) every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal.
Drug: Docetaxel
docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
Active Comparator: docetaxel
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
docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.

Detailed Description:
This trial began as a 2-arm study with a docetaxel-alone arm. When bevacizumab became widely available, it was converted to a 1-arm open-label trial of docetaxel/bevacizumab. Patients enrolled in the docetaxel-alone arm were permitted to cross over to docetaxel/bevacizumab. Patients received bevacizumab 15 mg/kg and docetaxel 75 mg/m2 intravenously (I.V.) every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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
    • Hemoglobin ≥ 9.0 g/dL
    • Creatinine ≤ 2.0 mg/dL
    • Total bilirubin < 1.0 x upper limit of normal (ULN) (patients with documents Gilbert's syndrome are eligible).
    • Alkaline phosphatase (AP) normal AND Angiotensin Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤ 2.5 times upper limit of normal (ULN) or AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN or AP ≤ 5 times ULN AND AST or ALT normal.

Exclusion Criteria

  • 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
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedure, fine needle aspiration or core biopsy within 7 days prior to beginning therapy
  • Proteinuria at baseline or clinically significant impairment of renal function. Subjects unexpectedly discovered to have > 1+ proteinuria at baseline should undergo a 24 hour urine collection, which must be an adequate collection and must demonstrate <1 gm of protein/24 hour to allow participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217672

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Translational Oncology Research International
National Cancer Institute (NCI)
University of California, Los Angeles
Investigators
Principal Investigator: Sara Hurvitz, MD Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Translational Oncology Research International
ClinicalTrials.gov Identifier: NCT00217672     History of Changes
Obsolete Identifiers: NCT00203398
Other Study ID Numbers: CDR0000442877  P30CA016042  UCLA-0501049-01  TORI-B-01 
Study First Received: September 20, 2005
Results First Received: September 21, 2015
Last Updated: February 25, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Translational Oncology Research International:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Docetaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016