- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00020189
Flavopiridol in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
A Phase II Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or metastatic head and neck cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Determine the standard response rate (complete response and partial response) and duration of response in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with flavopiridol.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the effects of anti-platelet agents, aspirin and clopidogrel bisulfate, on the pharmacology of flavopiridol in these patients.
- Determine the effects of prophylactic anticoagulation with anti-platelet agents, aspirin and clopidogrel bisulfate, on the incidence of flavopiridol-related thrombosis in these patients.
OUTLINE: Patients receive flavopiridol IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients also receive oral aspirin and clopidogrel bisulfate beginning on day 0 and continuing throughout the study.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 1-3 years.
Undersøgelsestype
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Maryland
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Bethesda, Maryland, Forenede Stater, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
Bethesda, Maryland, Forenede Stater, 20892
- Center for Cancer Research
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically proven squamous cell carcinoma of the head and neck
- Metastatic disease at diagnosis OR
- Persistent, metastatic, or recurrent disease after prior definitive surgery and/or radiotherapy
- No undifferentiated and nonkeratinizing carcinomas, including lymphoepitheliomas of all locations
- No nasopharynx tumors
Bidimensionally measurable disease
- Patients whose only measurable disease is within a prior radiotherapy port must have clearly progressive disease
- No metastatic or leptomeningeal CNS disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count greater than 100,000/mm^3
- Absolute granulocyte count greater than 1,500/mm^3
Hepatic:
- See Other (Prior/Concurrent Therapy)
- SGOT and SGPT less than 2.5 times normal
- Bilirubin less than 1.5 times normal
- No history of hypercoagulopathies (e.g., protein C deficiency, protein S deficiency, or lupus anticoagulant)
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
- Calcium no greater than normal
- No hypercalcemia refractory to bisphosphonates
Cardiovascular:
- No unstable or newly diagnosed angina pectoris
- No myocardial infarction within the past 6 months
- No class II-IV congestive heart failure
- No history of symptomatic carotid disease
- No concurrent asymptomatic carotid artery occlusion (70% or greater) in one or both arteries by Doppler ultrasound
- No symptomatic atherosclerosis
- No thrombotic events within the past 6 months
Pulmonary:
- No aspirin-induced asthma
Other:
- No inability to take aspirin or clopidogrel bisulfate due to contraindications, allergies, or pre-existing medical conditions (e.g., active peptic ulcer disease or history of undiagnosed non-occult, non-hemorrhoidal gastrointestinal or other bleeding sources within the past 6 months)
- No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy and recovered
- No prior flavopiridol
- No more than 3 prior systemic chemotherapy regimens for recurrent or metastatic disease
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except oral contraceptives
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior surgery and recovered
- No prior carotid endarterectomy or other revascularization surgery
Other:
- No other concurrent antineoplastic therapies
- No active anticoagulation with INR 1.5 or greater
- No low-molecular weight heparin or equivalent
- Concurrent bisphosphonates for calcium maintenance allowed
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Barbara A. Conley, MD, National Cancer Institute (NCI)
Datoer for undersøgelser
Studer store datoer
Studiestart
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
- ubehandlet metastatisk planehalskræft med okkult primær
- tilbagevendende metastatisk planehalskræft med okkult primær
- metastatisk pladecellekræft med okkult primært pladecellekræft
- stadium IV planocellulært karcinom i læben og mundhulen
- tilbagevendende pladecellekarcinom i læben og mundhulen
- stadium IV planocellulært karcinom i oropharynx
- tilbagevendende pladecellekarcinom i oropharynx
- stadium IV planocellulært karcinom i hypopharynx
- tilbagevendende pladecellekarcinom i hypopharynx
- stadium IV planocellulært karcinom i strubehovedet
- tilbagevendende pladecellekarcinom i strubehovedet
- stadium IV planocellulært karcinom i paranasale sinus og næsehulen
- tilbagevendende pladecellekarcinom i paranasale sinus og næsehulen
- tilbagevendende spytkirtelkræft
- stadium IV spytkirtelkræft
- tromboemboli
- spytkirtel planocellulært karcinom
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Embolisme og trombose
- Neoplasmer i hoved og hals
- Tromboemboli
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Blodpladeaggregationshæmmere
- Cyclooxygenase-hæmmere
- Antipyretika
- Purinerge P2Y-receptorantagonister
- Purinerge P2-receptorantagonister
- Purinerge antagonister
- Purinerge midler
- Antineoplastiske midler
- Vækststoffer
- Væksthæmmere
- Proteinkinasehæmmere
- Aspirin
- Clopidogrel
- Alvocidib
Andre undersøgelses-id-numre
- CDR0000068028
- NCI-00-C-0128
- MB-401
- NCI-T99-0066
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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