Metastatic Breast CancerPhase 1/2NCT00442260
Doxorubicin HCL Liposome Injection (DOXIL) in Combination With Abraxane in Patients With Metastatic Breast Cancer
A Phase 1/2 study testing DOXIL and Abraxane in people with Metastatic Breast Cancer, run by West Virginia University at 1 site in United States.
Trial summary
Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination with Abraxane (Abraxane) in Patients with Metastatic Breast Cancer (MBC) [Phase I and II] Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- DOXIL and Abraxane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Oct 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female over the age of 18.
- ECOG performance status 0-2.
- Patients with a biopsy proven or radiologically confirmed metastatic breast cancer.
- Chemotherapy naïve in the metastatic setting or had one prior regimen for metastatic breast cancer.
- Patients who had multiple non-chemotherapy agents for metastatic breast cancer are eligible i.e. hormonal therapies, Herceptin, Avastin etc.
- If they had received a taxane or anthracyclines in the adjuvant or metastatic setting, the interval should be more than 12 month and the cumulative dose of anthracycline will have to be taken into account (for both adjuvant and metastatic setting).
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- Patients who have Her2/neu negative breast cancer.
- No significant co-morbid conditions as determined by the investigator.
- Patients must have normal cardiac function, as evidenced by a left ventricular ejection fraction (LVEF) within institutional normal limits. A Multiple Gated Acquisition (MUGA) scan or echocardiogram (the same test must be used throughout the study) to evaluate LVEF must be done within 4 weeks (28 days).
- Normal laboratory values as explained below.
- No active malignancy in the past 5 years (other than non- melanomatous cutaneous cancer, cervical intraepithelial neoplasia, or in-situ cervical cancer).
- Ability to understand and the willingness to sign a written informed consent document.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan. See section for the evaluation of measurable disease. The protocol will employ the RECIST criteria.
- Negative serum or urine pregnancy test at screening for patients of child-bearing potential
- Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.
Who cannot join
- Pregnant or breast-feeding.
- Patients with central nervous system (CNS) metastatic disease can be excluded if it is diffuse involvement or cerebrospinal fluid (CSF) spread or metastasis not amenable to gamma knife surgery or neurosurgical intervention (Following neurosurgical removal of solitary or up to 3 metastasis or following gamma-knife procedure for up to 3 metastasis, patient can become eligible). For those patients with stable CNS metastasis for more than 12 months will be eligible for study.
- Evidence of significant co-morbid conditions or end organ dysfunction.
- Patients with Grade 3 or 4 neuropathy at baseline evaluation from any cause will also be excluded.
- Patients are permitted to receive radiation therapy (palliative or primary), but their study drugs will be held during the course of radiation therapy until hematopoietic recovery. The irradiated sites will not be used for response in the Phase II setting.
- Prior anthracycline dose exceeding 360 mg/m2 for doxorubicin (including Doxil) or 720 mg/m2 for epirubicin will make them ineligible.
- History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of DOXIL. Prior history of severe reaction to Taxol will also make them ineligible.
- Myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Trials Research Unit, West Virginia University
Morgantown, West Virginia, 26506-9260
About this study
Official title: Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination With Abraxane (Abraxane) in Patients With Metastatic Breast Cancer (MBC) [Phase I and II]
Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination with Abraxane (Abraxane) in Patients with Metastatic Breast Cancer (MBC) [Phase I and II]
Read the detailed description
Phase I Objectives
- To determine the Maximum Tolerated Dose (MTD) of the combination of (DOXIL) and Abraxane in patients with Metastatic Breast Cancer (MBC).
- Determine the dose-limiting toxicity (DLT) of DOXIL and Abraxane.
Phase II Objectives
Primary Objective
- To determine the response rate of DOXIL and Abraxane in patients with MBC.
Secondary Objectives
- To determine the time to disease progression in patients with MBC receiving DOXIL and Abraxane.
- To assess the tolerability of this regimen in women with MBC and assess toxicity profile
- Conditions
- Metastatic Breast Cancer
- Being tested
- DOXIL, Abraxane
- Keywords
- breast cancer, advanced breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOXILDrug
AbraxaneDrug
| Study group | Role | What they receive |
|---|---|---|
| Abraxane dose escalation + fixed dose DOXIL | Experimental | Limited dose-escalation study of Abraxane and fixed dose of DOXIL in order to identify correct dose and side effect profile of the combination. Receives: Drug: DOXIL; Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
This Trial Will Use DOXIL and Abraxane as First or Second Line Chemotherapy in Patients With a Diagnosis of Metastatic Breast Cancer (MBC).
Measured: Patients will be restaged every 3 cycles or approximately every 9 weeks. At the time of restaging, patients will have their disease status classified as complete response (CR), partial response (PR), progressive disease (PD) or stable disease (SD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Responsible party
- Sponsor
- Investigators
- Jame Abraham, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442260
- Sponsor's protocol ID
- DOXIL
- Status last verified
- Dec 2020
- First submitted
- 28 Feb 2007
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination With Abraxane (Abraxane) in Patients With Metastatic Breast Cancer (MBC) [Phase I and II]
- ClinicalTrials.gov ID
- NCT00442260
- Acronym / sponsor ID
- DOXIL
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer, advanced breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Study start
- Feb 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination with Abraxane (Abraxane) in Patients with Metastatic Breast Cancer (MBC) [Phase I and II]
Detailed description
Phase I Objectives
- To determine the Maximum Tolerated Dose (MTD) of the combination of (DOXIL) and Abraxane in patients with Metastatic Breast Cancer (MBC).
- Determine the dose-limiting toxicity (DLT) of DOXIL and Abraxane.
Phase II Objectives
Primary Objective
- To determine the response rate of DOXIL and Abraxane in patients with MBC.
Secondary Objectives
- To determine the time to disease progression in patients with MBC receiving DOXIL and Abraxane.
- To assess the tolerability of this regimen in women with MBC and assess toxicity profile
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abraxane dose escalation + fixed dose DOXIL | Experimental | Drug: DOXIL, Drug: AbraxaneLimited dose-escalation study of Abraxane and fixed dose of DOXIL in order to identify correct dose and side effect profile of the combination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female over the age of 18.
- ECOG performance status 0-2.
- Patients with a biopsy proven or radiologically confirmed metastatic breast cancer.
- Chemotherapy naïve in the metastatic setting or had one prior regimen for metastatic breast cancer.
- Patients who had multiple non-chemotherapy agents for metastatic breast cancer are eligible i.e. hormonal therapies, Herceptin, Avastin etc.
Key exclusion criteria (8 listed)
- Pregnant or breast-feeding.
- Patients with central nervous system (CNS) metastatic disease can be excluded if it is diffuse involvement or cerebrospinal fluid (CSF) spread or metastasis not amenable to gamma knife surgery or neurosurgical intervention (Following neurosurgical removal of solitary or up to 3 metastasis or following gamma-knife procedure for up to 3 metastasis, patient can become eligible). For those patients with stable CNS metastasis for more than 12 months will be eligible for study.
- Evidence of significant co-morbid conditions or end organ dysfunction.
- Patients with Grade 3 or 4 neuropathy at baseline evaluation from any cause will also be excluded.
- Patients are permitted to receive radiation therapy (palliative or primary), but their study drugs will be held during the course of radiation therapy until hematopoietic recovery. The irradiated sites will not be used for response in the Phase II setting.
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 |
|---|---|---|
| DOXIL | Drug | Abraxane dose escalation + fixed dose DOXIL |
| Abraxane | Drug | Abraxane dose escalation + fixed dose DOXIL |
Primary outcome
This Trial Will Use DOXIL and Abraxane as First or Second Line Chemotherapy in Patients With a Diagnosis of Metastatic Breast Cancer (MBC).
Time frame: Patients will be restaged every 3 cycles or approximately every 9 weeks. At the time of restaging, patients will have their disease status classified as complete response (CR), partial response (PR), progressive disease (PD) or stable disease (SD)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jame Abraham, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DOXIL and Abraxane in people with Metastatic Breast Cancer, run by West Virginia University 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 15 inclusion and 8 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 22 Jan 2021. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
This Trial Will Use DOXIL and Abraxane as First or Second Line Chemotherapy in Patients With a Diagnosis of Metastatic Breast Cancer (MBC). (time frame: Patients will be restaged every 3 cycles or approximately every 9 weeks. At the time of restaging, patients will have their disease status classified as complete response (CR), partial response (PR), progressive disease (PD) or stable disease (SD)). 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 22 Jan 2021.