- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00182702
Ixabepilone in Treating Patients With Metastatic, Recurrent, or Unresectable Kidney Cancer
A Phase II Trial of BMS 247550 (Ixabepilone) in Advanced Renal Cell Carcinoma
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with metastatic, recurrent, or unresectable renal cell carcinoma treated with ixabepilone.
SECONDARY OBJECTIVES:
I. Determine the progression-free and overall survival rates in patients treated with this drug.
II. Determine the toxicity of this drug in these patients. III. Correlate VHL gene mutations with response in patients treated with this drug.
IV. Correlate VHL pathway protein expression with response in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 9 weeks until disease progression and then every 3 months for up to 2 years.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60637-1470
- University of Chicago Comprehensive Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Histologically or cytologically confirmed renal cell carcinoma of 1 of the following subtypes:
- Clear cell
- Papillary, type I or II
- Chromophobe
- Collecting duct
- Medullary
- Metastatic, recurrent, or unresectable disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
No known active brain metastases requiring steroid or anticonvulsant therapy
- Patients with definitively treated brain metastases are eligible provided they are not on steroids or anticonvulsants AND show no evidence of disease progression for ≥ 3 months after completion of definitive therapy
- Performance status - ECOG 0-2
- At least 3 months
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Glomerular filtration rate ≥ 50 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No ongoing or active infection
- No HIV positivity
- No peripheral neuropathy > grade 1
- No psychiatric illness or social situation that would preclude study compliance
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug
- No history of severe hypersensitivity reaction to agents containing Cremophor® EL
No other active malignancy
- Curatively treated malignancies are allowed provided the risk of recurrent disease at the time of study enrollment is < 20%
- No other uncontrolled illness
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
No prior tubule inhibitors, including, but not limited to, any of the following:
- Vinca alkaloids (e.g., vinblastine, vincristine, or vinorelbine)
- Taxanes (e.g., docetaxel or paclitaxel)
- Epothilones
- No other concurrent chemotherapy
- See Disease Characteristics
- No concurrent hormonal therapy except steroids for adrenal failure or hypersensitivity prophylaxis or hormones for non-disease related conditions (e.g., insulin for diabetes)
- More than 4 weeks since prior radiotherapy and recovered
- No concurrent palliative radiotherapy
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treatment
Patients receive ixabepilone IV over 3 hours on day 1.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Korrelative undersøgelser
Givet IV
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Objective response rate (partial or complete)
Tidsramme: Up to 5 years
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Up to 5 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Progression-free survival (PFS)
Tidsramme: From the start of treatment to time of progression, assessed up to 5 years
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PFS rate will be estimated using the Kaplan-Meier method.
Median PFS time and its associated 90% confidence interval will be estimated using the method of Brookmeyer and Crowley.
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From the start of treatment to time of progression, assessed up to 5 years
|
Overall survival (OS)
Tidsramme: Up to 5 years
|
OS rate will be estimated using the Kaplan-Meier method.
Median OS time and its associated 90% confidence interval will be estimated using the method of Brookmeyer and Crowley.
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Up to 5 years
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Edwin Posadas, University of Chicago Comprehensive Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Nyresygdomme
- Urologiske sygdomme
- Adenocarcinom
- Neoplasmer, kirtel og epitel
- Nyre-neoplasmer
- Karcinom, nyrecelle
- Karcinom
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Epothilones
- Epothilone B
Andre undersøgelses-id-numre
- NCI-2012-02669
- N01CM62201 (U.S. NIH-bevilling/kontrakt)
- N01CM62209 (U.S. NIH-bevilling/kontrakt)
- 13850A
- CDR0000440071 (Registry Identifier: PDQ (Physician Data Query))
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