- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00005647
SU5416 and Paclitaxel in Treating Patients With Recurrent, Locally Advanced or Metastatic Cancer of the Head and Neck
A Phase I Pharmacokinetic, Pharmacodynamic, and Clinical Study of the Combination of the Angiogenesis Inhibitor SU5416 and Paclitaxel in Recurrent or Metastatic Carcinoma of the Head and Neck
RATIONALE: SU5416 may stop the growth of head and neck cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of SU5416 and paclitaxel in treating patients who have recurrent, locally advanced, or metastatic cancer of the head and neck.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Determine the maximum tolerated dose and safety of SU5416 and paclitaxel in patients with recurrent or metastatic head and neck cancer.
- Determine the antiangiogenesis effect of this combination regimen in these patients.
- Determine the toxicity, pharmacodynamic effects, and pharmacokinetic parameters of this combination.
OUTLINE: This is a dose escalation study.
Patients receive paclitaxel IV over one hour on day 1 and SU5416 IV over one hour on days 1 and 4. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paclitaxel and SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study within 9-15 months.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44106-5065
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Metastatic or loco-regionally recurrent malignancy of the head and neck (including salivary gland and thyroid) that is incurable by surgery or radiotherapy
- At least two distinct tumor masses OR
- One tumor mass at least 3 cm in diameter
- No brain metastases
- No pulmonary metastases as only site of disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC at least 3,500/mm3
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin greater than 9.0 g/dL
Hepatic:
- PT and PTT normal OR
- INR ratio less than 1.1
- Bilirubin less than 1.5 mg/dL
- AST and ALT less than 2 times upper limit of normal
Renal:
- Creatinine less than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No New York Heart Association class III or IV heart disease
- No uncompensated coronary artery disease
- No history of myocardial infarction or severe or unstable angina within the past 6 months
- No severe peripheral vascular disease
- No deep venous thrombosis or arterial thrombosis within the past 6 months
- No known hypercoagulable syndrome with predisposition to venous or arterial clots
Pulmonary:
- No pulmonary embolism within the past 6 months
Other:
- No prior cerebral hemorrhage
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 weeks since palliative chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
- At least 4 weeks since combined chemoradiotherapy and recovered
- Must be recovered from prior taxanes
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior large field radiotherapy and recovered
Surgery:
- Not specified
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Determine the maximum tolerated dose and safety of SU5416 and paclitaxel.
Tidsramme: Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
|
Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (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
Nøgleord
- tilbagevendende metastatisk planehalskræft med okkult primær
- metastatisk pladecellekræft med okkult primært pladecellekræft
- stadium III adenoid cystisk carcinom i mundhulen
- tilbagevendende pladecellekarcinom i læben og mundhulen
- tilbagevendende verrucous carcinom i mundhulen
- tilbagevendende mucoepidermoid karcinom i mundhulen
- tilbagevendende adenoid cystisk carcinom i mundhulen
- tilbagevendende pladecellekarcinom i oropharynx
- tilbagevendende lymfepitheliom i oropharynx
- tilbagevendende pladecellekarcinom i nasopharynx
- tilbagevendende lymfepitheliom i nasopharynx
- tilbagevendende pladecellekarcinom i hypopharynx
- tilbagevendende pladecellekarcinom i strubehovedet
- tilbagevendende verrucous carcinom i strubehovedet
- tilbagevendende pladecellekarcinom i paranasale sinus og næsehulen
- tilbagevendende esthesioneuroblastom i paranasale sinus og næsehulen
- tilbagevendende spytkirtelkræft
- anaplastisk kræft i skjoldbruskkirtlen
- tilbagevendende omvendt papilloma i paranasale sinus og næsehulen
- tilbagevendende hypopharyngeal cancer
- skjoldbruskkirtel medullært karcinom
- tilbagevendende kræft i skjoldbruskkirtlen
- stadium III follikulær skjoldbruskkirtelkræft
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer i hoved og hals
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Proteinkinasehæmmere
- Paclitaxel
- Semaxinib
Andre undersøgelses-id-numre
- CWRU1399
- U01CA062502 (U.S. NIH-bevilling/kontrakt)
- P30CA043703 (U.S. NIH-bevilling/kontrakt)
- CWRU-1399
- NCI-T99-0084
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