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View Clinical Trial (Medical Research Study)
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Bevacizumab and Paclitaxel, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, or Ixabepilone in Treating Patients With Locally Recurrent, Stage IIIB, or Stage IV Breast Cancer - NCT00785291-54601 (Clinical Trial 251134)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy251134.aspx
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| City: |
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La Crosse |
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State:
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WI |
| Zip Code: |
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54601 |
| Conditions: |
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Breast Cancer - Chemotherapeutic Agent Toxicity - Long-term Effects Secondary to Cancer Therapy in Adults - Neurotoxicity - Psychosocial Effects of Cancer and Its Treatment |
| Purpose: |
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RATIONALE: 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. Drugs used in chemotherapy, such
as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation, and ixabepilone, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. It is not yet known which treatment regimen is more effective
in treating patients with recurrent or metastatic breast cancer.
PURPOSE: This randomized phase III trial is studying bevacizumab to see how well it works
when given together with paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation,
or ixabepilone in treating patients with locally recurrent, stage IIIB, or stage IV breast
cancer.
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| Study summary: |
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OBJECTIVES:
Primary
- To compare the progression-free survival of patients with locally recurrent, stage IIIB
or IV breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation
(nab-paclitaxel) versus ixabepilone versus paclitaxel with concomitant bevacizumab.
Secondary
- To compare the objective response rate, duration of response, and time to treatment
failure in patients receiving nab-paclitaxel versus paclitaxel, and to separately
compare these endpoints in patients receiving ixabepilone versus paclitaxel.
- To compare the 12-month rate of progression in patients treated with these regimens.
- To compare toxicities in patients receiving these regimens, according to the rates of
grade 3/4 sensory neuropathy and the rates of peripheral neuropathy assessed by the
FACT/GOG neurotoxicity subscale.
- To compare overall survival of patients receiving these regimens.
- To prospectively collect data on sociodemographics, non-cancer morbidities, and receipt
of post-trial therapy to evaluate the role of potential disparities on survival from
cancer.
OUTLINE: This is a multicenter study. Patients are stratified according to taxane as
adjuvant therapy (yes or no) and estrogen receptor (ER) or progesterone (PgR) status (ER- or
PgR- positive vs both ER- and PgR- negative). Patients are randomized to 1 of 3 treatment
arms.
- Arm I (Weekly paclitaxel): Patients receive paclitaxel IV over 1 hour on days 1, 8, and
15 and bevacizumab IV over 30-90 minutes on days 1 and 15.
- Arm II (Weekly paclitaxel albumin-stabilized nanoparticle formulation
[nab-paclitaxel]): Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and
15 and bevacizumab as in arm I.
- Arm III (Weekly ixabepilone): Patients receive ixabepilone IV over 60 minutes on days
1, 8, and 15 and bevacizumab as in arm I.
In all arms, treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.
Patients complete questionnaires about peripheral neuropathy at baseline and before each
course of therapy. They also complete questionnaires about sociodemographics, non-cancer
comorbidities, social support, and post-trial therapy at baseline and periodically
thereafter.
After completion of study therapy, patients are followed every 6 months for 2 years and then
annually for up to 3 years. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Stage IIIB or IV (locally recurrent or metastatic) disease not amenable to local
therapy
- Measurable disease (target lesions), defined as ≥ 1 lesion that can be accurately
measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 2.0 cm with
conventional techniques or as ≥ 1 cm with spiral CT scan
- No non-measurable lesions, including any of the following:
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonitis
- Bone lesions
- Leptomeningeal disease
- Cystic lesions
- Abdominal masses not confirmed and followed by imaging techniques
- No prior chemotherapy regimen for metastatic or locally advanced breast cancer
- HER2/neu status must be known
- HER2- positive disease allowed, provided patient received prior trastuzumab
(Herceptin®) or lapatinib (documentation of progression on HER2-directed therapy
is not required)
- Hormone receptor status must be known
- Estrogen receptor (ER)- and progesterone receptor (PgR)-positive if ≥ 1% cells
are positive
- No progressing or untreated CNS metastases or leptomeningeal disease
- History of resected brain metastases with stable MRI scans for 3 months
including within the past 4 weeks allowed
- History of gamma-knife radiosurgery or whole-brain radiation with stable MRI
scans for 3 months, including within the past 4 weeks allowed
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG (Zubrod) performance status 0-1
- Life expectancy ≥ 12 weeks
- Granulocytes ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Creatinine ≤ 2.0 mg/dL
- Bilirubin < 1.5 mg/dL (unless due to Gilbert's syndrome)
- AST and ALT ≤ 2.5 times upper limit of normal
- Urine protein ≤ 1+
- Urine protein:creatinine ratio < 1 OR 24-hour urine < 1 g for urine protein ≥ 2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- History of seizures allowed if well controlled with standard medication
- No history of hypersensitivity to paclitaxel or Cremophor® EL CTCAE grade ≥ 3
- No other active malignancy except nonmelanoma skin cancer (patients are not
considered to have a "currently active" malignancy if they have completed therapy and
are considered by their physician to have less than 30% risk of relapse)
- No history of abdominal fistula or intra-abdominal abscess within 6 months prior to
study registration
- No history of gastrointestinal (GI) perforation within the past 12 months
- No history of significant bleeding episodes (e.g., hemoptysis, upper or lower GI
bleeding) within the past 6 months
- No history of stroke or transient ischemic attack within the past 6 months
- No history of clinically significant cardiovascular disease including any of the
following:
- Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg
and/or diastolic BP > 90 mm Hg on antihypertensive medications
- Prior history of hypersensitivity or hypertensive encephalopathy
- History of myocardial infarction or unstable angina within past 6 months
- NYHA congestive heart failure class II-IV
- Symptomatic peripheral vascular disease
- Significant vascular disease (e.g., aortic aneurysm or aortic dissection) or
arterial thrombotic events
- No serious, non-healing wound, ulcer, or bone fracture
- No significant traumatic injury in the past 28 days
- No peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Adjuvant or neoadjuvant taxane allowed, provided interval between completion of
adjuvant therapy and disease recurrence is ≥ 12 months
- At least 2 weeks since prior radiotherapy
- At least 7 days since core biopsy or other minor surgical procedure
- Vascular access device placement allowed
- At least 28 days since prior major surgical procedure or open biopsy and fully
recovered
- Prior trastuzumab or lapatinib ditosylate for HER2-overexpressing tumors allowed
- Prior bevacizumab allowed
- Prior and concurrent bisphosphonate treatment allowed
- No anticipated need for a major surgical procedure during the study
- No concurrent palliative radiotherapy
- No concurrent aprepitant
- No concurrent pegfilgrastim
- No other concurrent chemotherapy or anticancer hormone therapy
- Concurrent full-dose anticoagulants allowed but patient must be on a stable dose of
warfarin or low molecular weight heparin
- Anti-platelet therapy or on daily prophylactic-dose aspirin allowed
- Stable doses of anticoagulation for atrial fibrillation allowed |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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January 20, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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