Clinical trial · Interventional
Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors
A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors
NCT00415324CI-TRIAL-00014573completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1.
- interventionNames
- Drug: eribulin mesylate
- Drug: cisplatin
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0
- timeFrame
- 28 days
Secondary outcomes (2)
- measure
- Survival
- timeFrame
- From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.