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PHASE 2 STUDY OF BEVACIZUMAB IN COMBINATION WITH DOCETAXEL IN PATIENTS WITH ADVANCED BREAST CANCER


Phase 2
18 Years
N/A
Not Enrolling
Female
Recurrent Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

PHASE 2 STUDY OF BEVACIZUMAB IN COMBINATION WITH DOCETAXEL IN PATIENTS WITH ADVANCED BREAST CANCER


PRIMARY OBJECTIVES:

I. Determine the response rate in women with locally advanced or metastatic breast cancer
treated with bevacizumab and docetaxel.

II. Determine the side effects of this regimen in these patients. III. Correlate soluble
activated endothelial cell markers and adhesion molecules, quantitation of tumor and/or
endothelial cell apoptosis, and quantitation of microvessel density with clinical outcome in
patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on
weeks 1 and 3 and docetaxel IV over 60 minutes on weeks 1, 2, and 3. Treatment repeats every
4 weeks for up to 12 courses in the absence of unacceptable toxicity or disease progression.
After completion of 6 courses of combined treatment, patients with an ongoing response may
receive bevacizumab alone in the absence of disease progression.

PROJECTED ACCRUAL: A total of 16-27 patients will be accrued for this study within 14-27
months.


Inclusion Criteria:



- Histologically or cytologically confirmed breast cancer

- Local-regional recurrences or metastatic disease

- At least 1 unidimensionally measurable lesion at least 20 mm by conventional
techniques OR at least 10 mm by spiral CT scan

- No history or evidence of CNS disease (e.g., primary brain tumor or any brain
metastases)

- Hormone receptor status:

- Not specified

- Female

- Performance status - ECOG 0-2

- Performance status - Karnofsky 60-100%

- More than 3 months

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- No bleeding diathesis or coagulopathy

- Bilirubin normal

- AST/ALT no greater than 2.5 times upper limit of normal

- INR less than 1.5 (patients receiving warfarin)

- Creatinine normal

- Creatinine clearance at least 60 mL/min

- No baseline proteinuria

- Patients with proteinuria of 1+ or greater at baseline are allowed provided
24-hour urinary protein is less than 500 mg

- No symptomatic congestive heart failure

- No cardiac arrhythmia

- No uncontrolled hypertension

- No history of stroke

- No clinically significant peripheral artery disease

- No arterial thromboembolic event within the past 6 months, including any of the
following:

- Transient ischemic attack

- Cerebrovascular accident

- Unstable angina

- Myocardial infarction

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No seizures not controlled with standard medical therapy

- No prior allergic reactions attributed to compounds of similar chemical or biological
composition to study agents

- No psychiatric illness or social situation that would preclude study compliance

- No ongoing or active infection

- No other concurrent uncontrolled illness

- No non-healing wounds

- No significant traumatic injury within the past 28 days

- Prior adjuvant chemotherapy allowed (up to 1 regimen for metastatic disease)

- More than 6 months since prior taxane-containing adjuvant chemotherapy

- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
and recovered

- More than 3 weeks since prior radiotherapy

- More than 28 days since prior major surgery or open biopsy

- More than 7 days since prior fine needle aspirations other than in the breast

- More than 7 days since prior placement of a vascular access device

- No concurrent major surgical procedure

- No concurrent or recent full-dose oral or parenteral anticoagulants or thrombolytic
agents (except as required to maintain patency of preexisting, permanent indwelling
IV catheters)

- No other concurrent investigational agents

- No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal
anti-inflammatory medications (known to inhibit platelet function at doses used to
treat chronic inflammatory diseases)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Description:

The response rate will be estimated with exact binomial 95% confidence intervals.

Outcome Time Frame:

Up to 4 years

Safety Issue:

No

Principal Investigator

Charles Shapiro

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01433

NCT ID:

NCT00055861

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms

Name

Location

Ohio State University Medical CenterColumbus, Ohio  43210
University of Colorado Cancer Center - Anschutz Cancer PavilionAurora, Colorado  80045