Human Epidermal Growth Factor 2 Negative Carcinoma of BreastPhase 1NCT01288261
Paclitaxel and Bavituximab in Treating Patients With HER2-Negative Metastatic Breast Cancer
A Phase 1 study testing paclitaxel, bavituximab and laboratory biomarker analysis in people with Human Epidermal Growth Factor 2 Negative Carcinoma of Breast and Male Breast Cancer, run by University of Arizona at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, 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 bavituximab, can block tumor growth in different ways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Male Breast Cancer, Recurrent Breast Cancer
- What is being tested?
- paclitaxel, bavituximab and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jul 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent has been obtained
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed, Her-2 negative breast cancer with evidence of metastatic disease
- Measurable or evaluable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group (ECOG) Performance Status =< 2
- Adequate hematologic function (absolute neutrophil count [ANC] >= 1,500 cells/uL; hemoglobin >= 9 g/dL; platelets >= 100,000/uL and =< 500,000/uL)
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- Adequate renal function (serum creatinine =< 1.5 mg/dL or calculated creatinine clearance >= 60 ml/min)
- Adequate hepatic function (total or direct bilirubin =< Upper Limit of Normal (ULN), Alk Phos =< 4 x ULN)
- Prothrombin time international normalized ratio within institutional normal limits
- Activated partial thromboplastin time =< 1.5 x ULN
- New York Heart Association classification I or II
- Female patients must have a negative urine pregnancy test at prestudy (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)
Who cannot join
- Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease, Hemophilia)
- Any current evidence of clinically significant active bleeding
- Any history of significant thromboembolic events (i.e., deep vein thrombosis or pulmonary thromboembolism) within the last five years or requirement for ongoing therapy with oral or parenteral anticoagulants; central venous catheter-related thrombosis > 12 months ago and low dose anticoagulants to maintain patency of lines are allowed; patients taking anticoagulants (e.g., prophylactic heparin or enoxaparin) are required to observe the washout period of 1 week prior to study drug infusion on Study Day 1
- Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement, anti-estrogen); patients taking concurrent hormone therapy are required to observe the washout period of 2 weeks prior to study drug infusion on Study Day 1
- Grade 2 or higher peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities)
- More than one prior chemotherapy regimen for metastatic disease (prior adjuvant chemotherapy or any number of prior hormonal therapies are allowed)
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- Chemotherapy, immunotherapy or radiotherapy within 2 weeks of Study Day 1 or not having recovered from significant treatment-related side effects due to agents administered previously; patients who have receive nitrosoureas and mitomycin C therapy are required to observe the washout period of 6 weeks prior to study drug infusion on Study Day 1
- Allergy to polysorbate 80 or drugs containing polyoxyethylated castor oil (e.g. cyclosporine)
- Symptomatic or clinically active Central Nervous System (CNS) disease
- Major surgery within 4 weeks of Study Day 1
- Female patients pregnant or nursing
- All patients of reproductive potential must agree to use appropriate non-hormonal form of contraception
- Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
- Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
- A history of any condition requiring anti-platelet therapy (e.g., phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists) with the exception of general cardiovascular prophylaxis with aspirin
- Cardiac arrhythmia requiring medical therapy
- Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture)
- Requirement for chronic daily steroid use
- Known chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Trial of Weekly Paclitaxel in Combination With Bavituximab in Patients With Her-2 Negative Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, 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 bavituximab, 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. Giving paclitaxel together with bavituximab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of giving paclitaxel and bavituximab together in treating patients with Human Epidermal growth factor Receptor 2 (HER2 )-negative metastatic breast cancer
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy.
SECONDARY OBJECTIVES:
- To describe changes in pharmacodynamic markers and coagulation markers in response to single agent and combined therapy.
OUTLINE:
Patients receive paclitaxel intravenously (IV) on days 1, 8, and 15 and bavituximab IV on days 1, 8, 15, and 22 (days 15 and 22 only of course 1). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Male Breast Cancer, Recurrent Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
- Being tested
- paclitaxel, bavituximab, laboratory biomarker analysis, pharmacological study
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
Also called Anzatax, Asotax, TAX, Taxol
Given IV
bavituximabBiological
Also called Tarvacin
Given IV
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative study
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Paclitaxel, bavituximab, laboratory biomarker analysis and pharmacological study Receives: Drug: paclitaxel; Biological: bavituximab; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of grade 3 or higher toxicities associated with the combination therapy as classified using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: One year
Secondary outcomes (5)
Overall response rate of the regimen by RECIST
Measured: One year
Progression free survival (PFS)
Measured: One year
Measurable changes in levels of circulating endothelial cells (CEC), circulating endothelial progenitors (CEP), apoptotic CEC, and circulating tumor cells (CTC), as well as changes in cell-specific microparticle formation in response to therapy
Measured: One year
Activation of coagulation as measured by changes in D-dimer levels and platelet activation markers in response to therapy
Measured: One year
Collection and storage of additional plasma for further analysis of angiogenic markers (i.e., VCAM and VEGF)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Epidermal Growth Factor 2 Negative Carcinoma of BreastStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alison Stopeck, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288261
- Sponsor's protocol ID
- 10-0884-04
- Other IDs
- NCI-2011-00026, P30CA023074
- Status last verified
- Apr 2016
- First submitted
- 27 Jan 2011
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Weekly Paclitaxel in Combination With Bavituximab in Patients With Her-2 Negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01288261
- Acronym / sponsor ID
- 10-0884-04
- Conditions
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Male Breast Cancer, Recurrent Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, 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 bavituximab, 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. Giving paclitaxel together with bavituximab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of giving paclitaxel and bavituximab together in treating patients with Human Epidermal growth factor Receptor 2 (HER2 )-negative metastatic breast cancer
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy.
SECONDARY OBJECTIVES:
- To describe changes in pharmacodynamic markers and coagulation markers in response to single agent and combined therapy.
OUTLINE:
Patients receive paclitaxel intravenously (IV) on days 1, 8, and 15 and bavituximab IV on days 1, 8, 15, and 22 (days 15 and 22 only of course 1). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: paclitaxel, Biological: bavituximab, Other: laboratory biomarker analysis, Other: pharmacological studyPaclitaxel, bavituximab, laboratory biomarker analysis and pharmacological study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent has been obtained
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed, Her-2 negative breast cancer with evidence of metastatic disease
- Measurable or evaluable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group (ECOG) Performance Status =< 2
Key exclusion criteria (19 listed)
- Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease, Hemophilia)
- Any current evidence of clinically significant active bleeding
- Any history of significant thromboembolic events (i.e., deep vein thrombosis or pulmonary thromboembolism) within the last five years or requirement for ongoing therapy with oral or parenteral anticoagulants; central venous catheter-related thrombosis > 12 months ago and low dose anticoagulants to maintain patency of lines are allowed; patients taking anticoagulants (e.g., prophylactic heparin or enoxaparin) are required to observe the washout period of 1 week prior to study drug infusion on Study Day 1
- Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement, anti-estrogen); patients taking concurrent hormone therapy are required to observe the washout period of 2 weeks prior to study drug infusion on Study Day 1
- Grade 2 or higher peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxelAlso: Anzatax, Asotax, TAX, TaxolGiven IV | Drug | Treatment |
| bavituximabAlso: TarvacinGiven IV | Biological | Treatment |
| laboratory biomarker analysisCorrelative studies | Other | Treatment |
| pharmacological studyAlso: pharmacological studiesCorrelative study | Other | Treatment |
Primary outcome
Determination of grade 3 or higher toxicities associated with the combination therapy as classified using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: One year
5 secondary outcomes
Overall response rate of the regimen by RECIST
Time frame: One year
Progression free survival (PFS)
Time frame: One year
Measurable changes in levels of circulating endothelial cells (CEC), circulating endothelial progenitors (CEP), apoptotic CEC, and circulating tumor cells (CTC), as well as changes in cell-specific microparticle formation in response to therapy
Time frame: One year
Activation of coagulation as measured by changes in D-dimer levels and platelet activation markers in response to therapy
Time frame: One year
Collection and storage of additional plasma for further analysis of angiogenic markers (i.e., VCAM and VEGF)
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Stopeck principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing paclitaxel, bavituximab and laboratory biomarker analysis in people with Human Epidermal Growth Factor 2 Negative Carcinoma of Breast and Male Breast Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of grade 3 or higher toxicities associated with the combination therapy as classified using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.