- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00002901
Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function
PHASE I STUDY OF TAXOTERE IN PATIENTS WITH ADVANCED MALIGNANCIES AND VARYING DEGREES OF LIVER DYSFUNCTION
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of docetaxel in treating patients with advanced solid tumors that have not responded to standard therapy or for which there is no effective therapy.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel in patients with advanced solid tumors and varying degrees of liver dysfunction. II. Determine the effects of liver dysfunction in these patients on the plasma pharmacokinetics and pharmacodynamics of this therapy. III. Determine the utility of indocyanine green clearance and lidocaine metabolism as indicators of hepatic elimination of docetaxel in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver function (normal vs mild vs moderate vs severe). Patients receive docetaxel IV over 1 hour. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2 additional courses past CR. Within each abnormal liver function stratum, cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Within each abnormal liver function stratum, more than 6 patients are treated at the MTD, if possible. Patients in the normal liver function stratum are included as control patients and are followed for toxicity, but do not undergo dose escalation. Patients are followed for survival.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-18 months.
Studietype
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
California
-
Duarte, California, Forente stater, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
-
Los Angeles, California, Forente stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
-
Sacramento, California, Forente stater, 95817
- University of California Davis Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS: Histologically proven solid tumor that is refractory to standard therapy or for which no standard therapy exists Eligible tumors, include, but are not limited to, the following: Breast Ovarian Head and neck Non-small cell lung cancer Abnormal liver function Control patients with normal liver function are enrolled Brain metastases allowed if controlled by radiotherapy or surgery and neurologic status currently stable Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Not specified Menopausal status: Not specified Performance status: Karnofsky 50-100% Life expectancy: At least 1 month Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL OR Hematocrit at least 35% Hepatic: See Disease Characteristics No active acute hepatitis Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No concurrent cardiovascular disease that is poorly controlled with currently available treatment or of such severity as to preclude study Pulmonary: No concurrent pulmonary disease that is poorly controlled with currently available treatment or of such severity as to preclude study Other: No other concurrent illness (e.g., CNS disease) that is poorly controlled with currently available treatment or of such severity as to preclude study No severe infection requiring treatment Not pregnant Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 25% of bone marrow Surgery: See Disease Characteristics Recovered from major surgery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: James H. Doroshow, MD, City of Hope Comprehensive Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- stadium IV brystkreft
- stadium IIIA brystkreft
- tilbakevendende brystkreft
- stadium IIIB brystkreft
- tilbakevendende ikke-småcellet lungekreft
- stadium IIIA ikke-småcellet lungekreft
- stadium IIIB ikke-småcellet lungekreft
- stadium IV ikke-småcellet lungekreft
- uspesifisert voksen solid svulst, protokollspesifikk
- tilbakevendende metastatisk plateepitelkreft med okkult primær
- stadium III plateepitelkarsinom i leppe og munnhule
- stadium III basalcellekarsinom i leppen
- stadium III verrucous karsinom i munnhulen
- stadium III mucoepidermoid karsinom i munnhulen
- stadium III adenoid cystisk karsinom i munnhulen
- stadium IV plateepitelkarsinom i leppe og munnhule
- stadium IV basalcellekarsinom i leppen
- stadium IV verrucous karsinom i munnhulen
- stadium IV mucoepidermoid karsinom i munnhulen
- stadium IV adenoid cystisk karsinom i munnhulen
- tilbakevendende plateepitelkarsinom i leppe og munnhule
- tilbakevendende basalcellekarsinom i leppen
- tilbakevendende verrucous karsinom i munnhulen
- tilbakevendende mucoepidermoid karsinom i munnhulen
- tilbakevendende adenoid cystisk karsinom i munnhulen
- stadium III plateepitelkarsinom i orofarynx
- stadium III lymfepitelom i orofarynx
- stadium IV plateepitelkarsinom i orofarynx
- stadium IV lymfepitheliom i orofarynx
- tilbakevendende plateepitelkarsinom i orofarynx
- tilbakevendende lymfepitelom i orofarynx
- stadium III plateepitelkarsinom i nasopharynx
- stadium III lymfepitelom i nasofarynx
- stadium IV plateepitelkarsinom i nasopharynx
- stadium IV lymfepitheliom i nasofarynx
- tilbakevendende plateepitelkarsinom i nasopharynx
- tilbakevendende lymfepitheliom i nasofarynx
- stadium III plateepitelkarsinom i hypopharynx
- stadium IV plateepitelkarsinom i hypopharynx
- tilbakevendende plateepitelkarsinom i hypopharynx
- stadium III plateepitelkarsinom i strupehodet
- stadium III verrucous karsinom i strupehodet
- stadium IV plateepitelkarsinom i strupehodet
- stadium IV verrucous karsinom i strupehodet
- tilbakevendende plateepitelkarsinom i strupehodet
- tilbakevendende verrucous karsinom i strupehodet
- stadium III plateepitelkarsinom i paranasal sinus og nesehulen
- stadium III midtlinje letal granulom i paranasal sinus og nesehulen
- stadium III estesioneuroblastoma i paranasal sinus og nesehulen
- stadium IV plateepitelkarsinom i paranasal sinus og nesehulen
- stadium IV midtlinje letal granulom av paranasal sinus og nesehulen
- stadium IV esthesioneuroblastoma i paranasal sinus og nesehulen
- tilbakevendende plateepitelkarsinom i paranasal sinus og nesehulen
- tilbakevendende middellinje letal granulom i paranasal sinus og nesehulen
- tilbakevendende estesioneuroblastom i paranasal sinus og nesehulen
- stadium III eggstokepitelkreft
- stadium IV eggstokepitelkreft
- tilbakevendende eggstokepitelkreft
- eggstokksarkom
- borderline ovarieoverflate epitel-stromal tumor
- stromakreft i eggstokkene
- tilbakevendende kimcelletumor i eggstokkene
- stadium III eggstokkkimcelletumor
- stadium IV eggstokkkimcelletumor
- tilbakevendende invertert papillom i paranasal sinus og nesehulen
- stadium III invertert papilloma i paranasal sinus og nesehulen
- stadium IV invertert papilloma i paranasal sinus og nesehulen
- stadium IV nasofaryngeal kreft
Ytterligere relevante MeSH-vilkår
- Hudsykdommer
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Bryst sykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Brystneoplasmer
- Neoplasmer i hode og nakke
- Lungeneoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Docetaxel
Andre studie-ID-numre
- CDR0000065241
- P30CA033572 (U.S. NIH-stipend/kontrakt)
- U01CA062505 (U.S. NIH-stipend/kontrakt)
- CHNMC-PHI-08
- CHNMC-IRB-96118
- LAC-USC-PHI-08
- NCI-T96-0028H
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .