Breast CancerPhase 1NCT01795586
A Phase I Dose Escalation Study of Eribulin Plus Weekly Carboplatin for Metastatic Breast Patients
A Phase 1 study testing Eribulin and Carboplatin in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This study is being done to see how safe the combination of eribulin and carboplatin is and if it will work to help people with advanced breast cancer. Eribulin and carboplatin are both chemotherapy drugs. They work by killing cancer cells. A person is made up of cells which control every function in the body. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Eribulin and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2013to 11 May 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed breast cancer that is metastatic or if the disease is locally advanced and unresectable, then the standard curative measures are no longer effective.
- Must have received no more than 3 prior cytotoxic therapies in the metastatic setting. If patients demonstrated positive Her2/Neu disease they must have progressed on Herceptin. Once maximum tolerated dose is established; 10 patients are to be treated at that dose and must have received no more than 2 prior cytotoxic therapies in the metastatic setting.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky >60%
- Patients must have normal organ and marrow function as defined below:
- leukocytes ≥3,000/µL
- absolute neutrophil count ≥1,500/µL
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- platelets ≥100,000/µL
- total bilirubin within normal institutional limits
- aspartic transaminase (AST)/alanine transaminase (ALT) ≤2.5 X institutional upper limit of normal
- creatinine within normal institutional limits
- OR - creatinine clearance ≥60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) with one exception. However, may have bone only disease if an x-ray modality shows at least 1 cm of tumor.
- Female patient of childbearing potential has a negative serum pregnancy test beta human chorionic gonadotropin(β-hCG) and agree to use effective contraception during the study.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. If the patient has residual toxicity from prior therapy should be ≤ grade 1.
- Patients currently participating or has participated in a study with an investigational compound or device within 30 days of Day 1 of the study
- Patient has known active central nervous system (CNS) metastases or carcinomatous meningitis. Patients who have completed a course of therapy would be eligible for study if they are stable for 2 months prior to entry with no evidence of new or enlarging CNS metastasis and are off chronic steroids.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to eribulin mesylate or carboplatin
- Patients on Class Ia and III antiarrhythmics. The principal investigator (PI) and/or treating physician will evaluate the medications to make sure none would significantly interfere with corrected QT interval (QTc).
- Patient has known history of Hepatitis B or C or active Hepatitis A or HIV
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- Uncontrolled intercurrent illness 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. This includes symptomatic pleural effusions or ascites.
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with eribulin and carboplatin, breastfeeding should be discontinued if the mother is treated with eribulin and carboplatin.
- Peripheral neuropathy of severity greater than 1 as a baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase I Dose Escalation Study of Eribulin in Combination With Weekly Carboplatin for the Treatment of Metastatic Breast Cancer
This study is being done to see how safe the combination of eribulin and carboplatin is and if it will work to help people with advanced breast cancer. Eribulin and carboplatin are both chemotherapy drugs. They work by killing cancer cells. A person is made up of cells which control every function in the body. Some cells stop working like they should and become cancer cells. These cancer cells grow and multiply rapidly and can cause destruction to normal body organs. Eribulin and carboplatin have both been approved by United States Food and Drug Administration (FDA) for use in the treatment of breast cancer. The combination of these two drugs and the safest dose of eribulin to use is experimental.
- Conditions
- Breast Cancer
- Being tested
- Eribulin, Carboplatin
- Keywords
- breast - female, advanced breast cancer, histologically confirmed, cytologically confirmed, metastatic, locally advanced, unresectable
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EribulinDrug
Also called Halaven, eribulin mesylate
Eribulin will be administered on days 1 and 8 slow IV push over 2 to 5 minutes. Premedications will be given per institutional guidelines.
Level 1: 0.9 mg/m^2; Level 2: 1.1 mg/m^2; Level 3: 1.4 mg/m^2
CarboplatinDrug
Also called CBDCA, Paraplatin
Carboplatin will be administered intravenously on day 1 and day 8 of each cycle, immediately following eribulin infusion at a dose of area-under-the-curve (AUC) 2 over 30 minutes in 250 ML of 0.9 % normal saline. Carboplatin dose will be calculated using the Calvert formula using AUC of 2 as follows: Carboplatin dose (mg) = 2 X (GFR + 25).
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Every patient will receive eribulin and carboplatin. Each cycle is 21 days (or 3 weeks). Eribulin and carboplatin will be given intravenously on days 1 and 8 of each cycle. Receives: Drug: Eribulin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
The primary objective of the trial is to determine the safety and tolerability of eribulin mesylate and carboplatin in combination. The primary safety endpoint is dose limiting toxicity (DLT). The MTD is defined as the dose at which the percentage of patients experiencing a DLT is the closest to 30%. Planned doses for evaluation of eribulin mesylate include 0.9, 1.1, and 1.4 mg/m^2.
Measured: 30 months
Secondary outcomes (1)
Response Rate (RR)
Response rate will be provided for the subjects in the study overall. Response rates and 95% confidence intervals will be provided. Eribulin mesylate pharmacokinetic variables: peak concentration (CPeak) and trough plasma concentrations (Ctrough) will be calculated as appropriate and summary statistics will be provided.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study start6 Feb 2013
- Primary completion24 Feb 2015
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Heather Han, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795586
- Sponsor's protocol ID
- MCC-17169
- Other IDs
- HAL-IIS-014-11
- Status last verified
- Oct 2022
- First submitted
- 18 Feb 2013
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of Eribulin in Combination With Weekly Carboplatin for the Treatment of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01795586
- Acronym / sponsor ID
- MCC-17169
- Conditions
- Breast Cancer
- Keywords
- breast - female, advanced breast cancer, histologically confirmed, cytologically confirmed, metastatic, locally advanced, unresectable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- 6 Feb 2013 (actual)
- Primary completion
- 24 Feb 2015 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 20 Feb 2013 (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.
This study is being done to see how safe the combination of eribulin and carboplatin is and if it will work to help people with advanced breast cancer. Eribulin and carboplatin are both chemotherapy drugs. They work by killing cancer cells. A person is made up of cells which control every function in the body. Some cells stop working like they should and become cancer cells. These cancer cells grow and multiply rapidly and can cause destruction to normal body organs. Eribulin and carboplatin have both been approved by United States Food and Drug Administration (FDA) for use in the treatment of breast cancer. The combination of these two drugs and the safest dose of eribulin to use is experimental.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: Eribulin, Drug: CarboplatinEvery patient will receive eribulin and carboplatin. Each cycle is 21 days (or 3 weeks). Eribulin and carboplatin will be given intravenously on days 1 and 8 of each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically or cytologically confirmed breast cancer that is metastatic or if the disease is locally advanced and unresectable, then the standard curative measures are no longer effective.
- Must have received no more than 3 prior cytotoxic therapies in the metastatic setting. If patients demonstrated positive Her2/Neu disease they must have progressed on Herceptin. Once maximum tolerated dose is established; 10 patients are to be treated at that dose and must have received no more than 2 prior cytotoxic therapies in the metastatic setting.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky >60%
- Patients must have normal organ and marrow function as defined below:
- leukocytes ≥3,000/µL
Key exclusion criteria (9 listed)
- Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. If the patient has residual toxicity from prior therapy should be ≤ grade 1.
- Patients currently participating or has participated in a study with an investigational compound or device within 30 days of Day 1 of the study
- Patient has known active central nervous system (CNS) metastases or carcinomatous meningitis. Patients who have completed a course of therapy would be eligible for study if they are stable for 2 months prior to entry with no evidence of new or enlarging CNS metastasis and are off chronic steroids.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to eribulin mesylate or carboplatin
- Patients on Class Ia and III antiarrhythmics. The principal investigator (PI) and/or treating physician will evaluate the medications to make sure none would significantly interfere with corrected QT interval (QTc).
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 |
|---|---|---|
| EribulinAlso: Halaven, eribulin mesylateEribulin will be administered on days 1 and 8 slow IV push over 2 to 5 minutes. Premedications will be given per institutional guidelines. Level 1: 0.9 mg/m^2; Level 2: 1.1 mg/m^2; Level 3: 1.4 mg/m^2 | Drug | Dose Escalation |
| CarboplatinAlso: CBDCA, ParaplatinCarboplatin will be administered intravenously on day 1 and day 8 of each cycle, immediately following eribulin infusion at a dose of area-under-the-curve (AUC) 2 over 30 minutes in 250 ML of 0.9 % normal saline. Carboplatin dose will be calculated using the Calvert formula using AUC of 2 as follows: Carboplatin dose (mg) = 2 X (GFR + 25). | Drug | Dose Escalation |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 30 months
The primary objective of the trial is to determine the safety and tolerability of eribulin mesylate and carboplatin in combination. The primary safety endpoint is dose limiting toxicity (DLT). The MTD is defined as the dose at which the percentage of patients experiencing a DLT is the closest to 30%. Planned doses for evaluation of eribulin mesylate include 0.9, 1.1, and 1.4 mg/m^2.
1 secondary outcome
Response Rate (RR)
Time frame: 30 months
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 31 Oct 2022.
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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.
Heather Han, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
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 Eribulin and Carboplatin in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 9 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 31 Oct 2022. 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?
Maximum Tolerated Dose (MTD) (time frame: 30 months). 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 31 Oct 2022.