Metastatic Breast CancerPhase 2NCT00627978
Phase II Study of Ixabepilone in Metastatic Breast Cancer and Its Effects on the Ultrastructure of Neurons
A Phase 2 study testing ixabepilone in people with Metastatic Breast Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Primary Objectives Assess ultrastructure changes in dermal myelinated nerves of patients who receive ixabepilone chemotherapy Detailed characterization of peripheral neuropathy in patients who receive ixabepilone Secondary Objectives Clinical benefit rate Time to progression ( TTP) Toxicity Exploratory studies… 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?
- ixabepilone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jan 2011
- Phase
- Phase 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
- Ability to understand and the willingness to sign a written informed consent document.
- Histologic or cytologic diagnosis of adenocarcinoma originating in the breast.
- Evidence that the cancer is metastatic or locally advanced and not curable by local measures (i.e., surgery, radiation).
- NOTE: There is no limit on number of prior chemotherapy regimens received.
- Karnofsky performance status (KPS) score of 70 - 100; (Appendix 1).
- Life expectancy of at least 12 weeks.
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- Adequate recovery of drug related toxicities from prior systemic therapy (recovery to < = Grade 1 except for Grade 2 fatigue and alopecia).
- Adequate recovery from recent surgery and radiation therapy. At least one week must have elapsed from the time of a minor surgery and/or focal/palliative radiation therapy; at least 3 weeks for major surgery and other radiation therapy.
- Women or Men, age > = 18 years.
- Patients must have normal organ and marrow function as defined below:
- Hematologic function with absolute neutrophils ≥ 1,500/mm3 and/or platelets > 125,000/mm3
- Hepatic function with serum bilirubin less than 1.5 times the upper institutional limits of normal, ALT ≤ 2.5 times the upper institutional limits of normal (≤ 5 times the upper institutional limits of normal if documented hepatic metastases are present)
- Renal function with serum creatinine ≤ 1.5 times the upper limit of normal
- Women of childbearing potential (WOCBP) and men with partners who are of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.
- WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea > = 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL). Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
- Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Who cannot join
- Patients with known and active brain and/or leptomeningeal metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- CTC Grade 2 or greater neuropathy (motor or sensory) at study entry.
- Prior treatment with ixabepilone.
- Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy, including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known history of HIV infection.
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
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- Patients may not be receiving any other concurrent chemotherapy, hormonal therapy, immunotherapy regimens or radiation therapy, standard or investigational.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ixabepilone.
- Known prior severe hypersensitivity reactions to agents containing CremophorEL.
- Patients may not be receiving any prohibited therapies and/or medications.
- Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell University
New York, New York, 10021
About this study
Official title: Phase II Study of Ixabepilone in Patients With Metastatic Breast Cancer and a Prospective Evaluation of Its Effects on the Ultrastructure of Neurons
Primary Objectives
- Assess ultrastructure changes in dermal myelinated nerves of patients who receive ixabepilone chemotherapy
- Detailed characterization of peripheral neuropathy in patients who receive ixabepilone
Secondary Objectives
- Clinical benefit rate
- Time to progression ( TTP)
- Toxicity
- Exploratory studies:
- Relation of MDR 1 and TRKA polymorphisms to evolution of ultrastructural neurologic changes observed in neurons.
- Relation of NGF, IL8, and IL10 to the development of clinical symptoms and ultrastructural changes in neurons.
Read the detailed description
Eligible patient population:
- Stage 4 breast cancer
- Resolution from toxicity of prior therapy to ≤ CTC grade 1 ( except alopecia)
- No limit on prior number of therapies to treat cancer
- Adequate organ function
- Life expectancy greater than 3 months
Treatment: ixabepilone 40 mg/m2 Q3w over 3 hours
Evaluation on Study:
- Efficacy evaluation:
- Baseline CT chest, abdomen and pelvis and bone scan within 4 weeks of starting therapy
- Evaluation of disease every 2 cycles of chemotherapy
- Ongoing toxicity evaluation using NCI CTC 3.
II. Neurological evaluation:
- Detailed neurologic exam using Neuropathy Assessment Instrument (represents a standard neurological exam)
- Serum NGF, IL 8,10, prior to starting therapy and prior to each cycle of ixabepilone
- DNA for assessment of TRK A and MDR1 polymorphisms
- Punch biopsy of skin prior to starting therapy and after every 2 cycles. Laboratory evaluation of peripheral nerve biopsies will be conducted at Rockefeller University under the direction of Dr. Carlson in Dr. Strickland's Lab.
- Conditions
- Metastatic Breast Cancer
- Being tested
- ixabepilone
- Keywords
- breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ixabepiloneDrug
ixabepilone 40 mg/m2 Q3w over 3 hours
| Study group | Role | What they receive |
|---|---|---|
| Ixabepilone | Experimental | Participants are treated with Ixabepilone. Receives: Drug: ixabepilone |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axons With Abnormal Morphology
Digital photographs for morphometry were captured at a magnification of 8000-16,000x and the photos were uploaded onto an imaging platform of transmission electron microscope (iTEM) (Olympus, Mu¨nster, Germany). The figures were enlarged by 50%, and an individual linear array was used to measure the axonal diameter (cross-sectional area) and the number of unmyelinated axons per Remak Schwann cell was enumerated according to the established methodology.
Measured: Baseline and Over 7 cycles of treatment, approximately 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2011
- Study completionJan 2011
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 Weill Medical College of Cornell 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Linda Vahdat, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627978
- Sponsor's protocol ID
- 0707009284
- Status last verified
- May 2018
- First submitted
- 22 Feb 2008
- Last updated
- 26 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Ixabepilone in Patients With Metastatic Breast Cancer and a Prospective Evaluation of Its Effects on the Ultrastructure of Neurons
- ClinicalTrials.gov ID
- NCT00627978
- Acronym / sponsor ID
- 0707009284
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Nov 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 Mar 2008 (estimated)
- Results
- Posted 13 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives
- Assess ultrastructure changes in dermal myelinated nerves of patients who receive ixabepilone chemotherapy
- Detailed characterization of peripheral neuropathy in patients who receive ixabepilone
Secondary Objectives
- Clinical benefit rate
- Time to progression ( TTP)
- Toxicity
- Exploratory studies:
- Relation of MDR 1 and TRKA polymorphisms to evolution of ultrastructural neurologic changes observed in neurons.
- Relation of NGF, IL8, and IL10 to the development of clinical symptoms and ultrastructural changes in neurons.
Detailed description
Eligible patient population:
- Stage 4 breast cancer
- Resolution from toxicity of prior therapy to ≤ CTC grade 1 ( except alopecia)
- No limit on prior number of therapies to treat cancer
- Adequate organ function
- Life expectancy greater than 3 months
Treatment: ixabepilone 40 mg/m2 Q3w over 3 hours
Evaluation on Study:
- Efficacy evaluation:
- Baseline CT chest, abdomen and pelvis and bone scan within 4 weeks of starting therapy
- Evaluation of disease every 2 cycles of chemotherapy
- Ongoing toxicity evaluation using NCI CTC 3.
II. Neurological evaluation:
- Detailed neurologic exam using Neuropathy Assessment Instrument (represents a standard neurological exam)
- Serum NGF, IL 8,10, prior to starting therapy and prior to each cycle of ixabepilone
- DNA for assessment of TRK A and MDR1 polymorphisms
- Punch biopsy of skin prior to starting therapy and after every 2 cycles. Laboratory evaluation of peripheral nerve biopsies will be conducted at Rockefeller University under the direction of Dr. Carlson in Dr. Strickland's Lab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ixabepilone | Experimental | Drug: ixabepiloneParticipants are treated with Ixabepilone. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Ability to understand and the willingness to sign a written informed consent document.
- Histologic or cytologic diagnosis of adenocarcinoma originating in the breast.
- Evidence that the cancer is metastatic or locally advanced and not curable by local measures (i.e., surgery, radiation).
- NOTE: There is no limit on number of prior chemotherapy regimens received.
- Karnofsky performance status (KPS) score of 70 - 100; (Appendix 1).
Key exclusion criteria (11 listed)
- Patients with known and active brain and/or leptomeningeal metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- CTC Grade 2 or greater neuropathy (motor or sensory) at study entry.
- Prior treatment with ixabepilone.
- Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy, including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known history of HIV infection.
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 |
|---|---|---|
| ixabepiloneixabepilone 40 mg/m2 Q3w over 3 hours | Drug | Ixabepilone |
Primary outcome
Axons With Abnormal Morphology
Time frame: Baseline and Over 7 cycles of treatment, approximately 21 weeks
Digital photographs for morphometry were captured at a magnification of 8000-16,000x and the photos were uploaded onto an imaging platform of transmission electron microscope (iTEM) (Olympus, Mu¨nster, Germany). The figures were enlarged by 50%, and an individual linear array was used to measure the axonal diameter (cross-sectional area) and the number of unmyelinated axons per Remak Schwann cell was enumerated according to the established methodology.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Linda Vahdat, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ixabepilone in people with Metastatic Breast Cancer, run by Weill Medical College of Cornell 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 17 inclusion and 11 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 26 Jun 2018. 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 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 13 Jul 2017). 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?
Axons With Abnormal Morphology (time frame: Baseline and Over 7 cycles of treatment, approximately 21 weeks). 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 26 Jun 2018.