- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00415324
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
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Primary Objectives:
I. 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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
California
-
Duarte, California, Förenta staterna, 91010
- City of Hope Medical Center
-
Duarte, California, Förenta staterna, 91010
- City of Hope
-
Los Angeles, California, Förenta staterna, 90033
- University of Southern California/Norris Cancer Center
-
Sacramento, California, Förenta staterna, 95817
- University of California at Davis Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Arm 1
Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1.
|
Givet IV
Andra namn:
Givet IV
Andra namn:
korrelativ studie
Andra namn:
korrelativ studie
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0
Tidsram: 28 days
|
28 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Survival
Tidsram: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 8 weeks
|
Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.
|
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
Tidsram: Up to 8 weeks
|
Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.
|
Up to 8 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Marianna Koczywas, City of Hope Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NCI-2009-00168 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- P30CA033572 (U.S.S. NIH-anslag/kontrakt)
- U01CA062505 (U.S.S. NIH-anslag/kontrakt)
- PHI-55 (Annan identifierare: City of Hope Medical Center)
- CDR0000518290
- 7427 (Annan identifierare: CTEP)
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