Expired Study
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Los Angeles, California 90095


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.


Study summary:

OBJECTIVES: Primary - Compare the antitumor activity of docetaxel with vs without bevacizumab, in terms of time to disease progression, in women with HER2-negative stage IV breast cancer. Secondary - Compare response rates, duration of response, and overall survival of patients treated with these regimens. - Compare the safety and toxicity of these regimens in these patients. OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to prior adjuvant and/or neoadjuvant chemotherapy (none vs prior chemotherapy without a taxane vs prior chemotherapy with a taxane). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience unacceptable toxicity due to docetaxel may continue on bevacizumab alone until disease progression or bevacizumab-related unacceptable toxicity. After completion of study treatment, patients are followed within 30 days and then every 12 weeks thereafter. PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study within 3 months.


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 AST or 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-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.


Study is Available At:


Original ID:

CDR0000442877


NCT ID:

NCT00217672


Secondary ID:

P30CA016042


Study Acronym:


Brief Title:

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


Official Title:

A Randomized Phase II Trial of Docetaxel With or Without Bevacizumab as First-Line Therapy for HER2-Negative Metastatic Breast Cancer


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Translational Oncology Research International


Oversight Authority:

  • United States: Federal Government
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

107


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sara Hurvitz, MD
Principal Investigator
Jonsson Comprehensive Cancer Center

Study Dates

Start Date:May 2005
Primary Completion Date:September 2006
Primary Completion Type:Actual
Verification Date:September 2010
Last Changed Date:September 1, 2010
First Received Date:September 20, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Antitumor activity
Time Frame:Time to disease progression
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Comparison of response rates, duration of response, and overall survival
Time Frame:Time of death
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Comparison of safety and toxicity
Time Frame:When adverse events occur
Safety Issues:True

Study Interventions

Intervention Type:Biological
Name:bevacizumab
Description:15 mg/kg IV every 3 weeks. Subjects continue on study until disease progression, unacceptable toxicity, or withdrawal of patient consent.
Arm Name:Arm 1
Other Name:Avastin
Intervention Type:Drug
Name:docetaxel
Description:75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
Arm Name:Arm 1
Other Name:Taxotere

Study Arms

Study Arm Type:Experimental
Arm Name:Arm 1
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Translational Oncology Research International
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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