Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00415324
Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing eribulin mesylate, cisplatin and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 4 sites in United States.
Trial summary
This trial is studying the side effects and best dose of eribulin mesylate and cisplatin in treating patients with advanced solid tumors.Drugs used in chemotherapy, such as eribulin mesylate and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- eribulin mesylate, cisplatin and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2006to May 2014
- 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
- Histologically confirmed malignant solid tumor
- Advanced disease, meeting both of the following criteria: Metastatic or unresectable disease and standard curative or palliative measures do not exist or are no longer effective.
- No known active brain metastases
- Life expectancy > 3 months
- ECOG performance status 0-2
- Bilirubin normal
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- No uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situation that would limit study compliance.
- Negative pregnancy test
- Fertile patients must use effective contraception
- Recovered from prior therapy
- No prior chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C).
- No prior targeted therapy within the past 4 weeks
- No prior immunotherapy within the past 4 weeks
- No prior radiotherapy within the past 4 weeks.
- No more than 2 prior chemotherapy regimens for advanced solid tumors.
- No other concurrent investigational agents. Bisphosphonate therapy (e.g., pamidronate or zolendronate) is not considered investigational therapy.
- No concurrent antiretroviral therapy for HIV-positive patients.
- No other concurrent anticancer agents or therapies.
- Tumor has spread to other parts of the body or cannot be removed by surgery.
- More than 4 weeks since chemotherapy, biological therapy, or radiation therapy.
- No more than two previous chemotherapy regimens for advanced solid tumor.
- WBC >= 3,000/mm^3
- Platelet count >= 100,000/mm^3
- Creatinine clearance >= 60 mL/min
- Absolute neutrophil count >= 1,500/mm³
- AST and ALT =< 2.5 times upper limit of normal
- No prior cumulative cisplatin dose > 300 mg/m^2
- No preexisting neuropathy <= grade 2
- Not pregnant or nursing
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
City of Hope Medical Center
Duarte, California, 91010
City of Hope
Duarte, California, 91010
University of Southern California/Norris Cancer Center
Los Angeles, California, 90033
University of California at Davis Cancer Center
Sacramento, California, 95817
About this study
Official title: A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors
This trial is studying the side effects and best dose of eribulin mesylate and cisplatin in treating patients with advanced solid tumors.Drugs used in chemotherapy, such as eribulin mesylate and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Read the detailed description
Primary Objectives:
- To determine the maximum tolerated dose of E7389 and cisplatin in patients with advanced solid tumors.
II. To determine the safety and toxicity of this regimen in these patients. III. To determine the pharmacokinetics of this regimen in these patients.
Outline: This is a multicenter, dose-escalation study. Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 8 weeks.
- Being tested
- eribulin mesylate, cisplatin, laboratory biomarker analysis, pharmacological study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eribulin mesylateDrug
Also called B1939, E7389, ER-086526, halichrondrin B analog
Given IV
cisplatinDrug
Also called CACP, CDDP, CPDD, DDP
Given IV
laboratory biomarker analysisOther
correlative study
Also called pharmacological studies
correlative study
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Receives: Drug: eribulin mesylate; Drug: cisplatin; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0
Measured: 28 days
Secondary outcomes (2)
Survival
Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.
Measured: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 8 weeks
Time to failure
Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marianna Koczywas, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415324
- Sponsor's protocol ID
- NCI-2009-00168
- Other IDs
- NCI-2009-00168, PHI-55, CDR0000518290, PHI-55, 7427, U01CA062505, P30CA033572
- Status last verified
- Apr 2014
- First submitted
- 20 Dec 2006
- Last updated
- 20 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00415324
- Acronym / sponsor ID
- NCI-2009-00168
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2006
- Primary completion
- May 2014 (actual)
- First posted
- 22 Dec 2006 (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 trial is studying the side effects and best dose of eribulin mesylate and cisplatin in treating patients with advanced solid tumors.Drugs used in chemotherapy, such as eribulin mesylate and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Detailed description
Primary Objectives:
- To determine the maximum tolerated dose of E7389 and cisplatin in patients with advanced solid tumors.
II. To determine the safety and toxicity of this regimen in these patients. III. To determine the pharmacokinetics of this regimen in these patients.
Outline: This is a multicenter, dose-escalation study. Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: eribulin mesylate, Drug: cisplatin, Other: laboratory biomarker analysis, Other: pharmacological studyPatients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Histologically confirmed malignant solid tumor
- Advanced disease, meeting both of the following criteria: Metastatic or unresectable disease and standard curative or palliative measures do not exist or are no longer effective.
- No known active brain metastases
- Life expectancy > 3 months
- ECOG performance status 0-2
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| eribulin mesylateAlso: B1939, E7389, ER-086526, halichrondrin B analogGiven IV | Drug | Arm 1 |
| cisplatinAlso: CACP, CDDP, CPDD, DDPGiven IV | Drug | Arm 1 |
| laboratory biomarker analysiscorrelative study | Other | Arm 1 |
| pharmacological studyAlso: pharmacological studiescorrelative study | Other | Arm 1 |
Primary outcome
Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0
Time frame: 28 days
2 secondary outcomes
Survival
Time frame: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 8 weeks
Time to failure
Time frame: Up to 8 weeks
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 20 May 2014.
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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.
Marianna Koczywas principal investigator
City of Hope Medical Center
4 sites 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 mesylate, cisplatin and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 4 sites 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 29 inclusion and 0 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0 (time frame: 28 days). 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 20 May 2014.