- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00042861
UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors
A Phase I Pharmacologic Trial Of Infusional UCN-01 Given With A Weekly Schedule Of 5-Fluorouracil And Leucovorin
RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining UCN-01, fluorouracil, and leucovorin in treating patients who have metastatic or unresectable solid tumors.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
- Determine the maximum tolerated dose of fluorouracil when given in combination with UCN-01 and leucovorin calcium in patients with metastatic or unresectable solid tumors.
- Determine the clinical toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of these drugs in these patients.
- Correlate, if possible, the pharmacokinetics of these drugs with clinical toxicity in these patients.
- Assess the pharmacodynamic effects of these drugs in these patients.
- Assess any clinical activity of this regimen in patients with measurable disease.
OUTLINE: This is a dose-escalation study of fluorouracil (5-FU).
Patients receive leucovorin calcium (CF) IV over 2 hours and 5-FU IV (at the midpoint of CF administration) on day 1, followed by UCN-01 IV over 36-72 hours, on weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 5-FU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The recommended phase II dose (RPIID) is defined as the dose preceding the MTD. At least 6 additional patients are treated at the RPIID.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 16 months.
Studientyp
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Maryland
-
Bethesda, Maryland, Vereinigte Staaten, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor that is metastatic or unresectable and for which no standard curative or palliative measures exist or are effective
- No brain metastases or primary CNS malignancy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- AST and ALT no greater than 3 times upper limit of normal
Renal
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- No known active coronary artery disease
Pulmonary
- No pulmonary dysfunction
Other
- HIV negative
- No history of unusually severe and/or prolonged toxicity during prior therapy with fluorouracil (5-FU) or 5-FU prodrugs
- No diabetes mellitus requiring insulin or oral hypoglycemic therapy
- No ongoing or active infection requiring IV antibiotics
- No other serious concurrent medical illness that would preclude study
- No psychiatric illness or social situations that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent cytokines during the first course of therapy
Chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy
- No concurrent systemic corticosteroids
Radiotherapy
- At least 2 weeks since prior radiotherapy and recovered
- No prior pulmonary or mediastinal radiation exceeding 40 Gy
Surgery
- Recovered from prior surgery
Other
- No other concurrent investigational agents
- No concurrent cimetidine
- No concurrent sorivudine or brivudine
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Jean L. Grem, MD, National Cancer Institute (NCI)
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Schutzmittel
- Mikronährstoffe
- Proteinkinase-Inhibitoren
- Vitamine
- Calciumregulierende Hormone und Wirkstoffe
- Gegenmittel
- Vitamin B-Komplex
- Fluorouracil
- Leucovorin
- Kalzium
- Levoleucovorin
- 7-Hydroxystaurosporin
Andere Studien-ID-Nummern
- CDR0000069478
- NCI-NAVY-01-04
- NCI-5535
- NCI-02-C-0222
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Fluorouracil
-
CStone PharmaceuticalsAktiv, nicht rekrutierendNicht resezierbares, lokal fortgeschrittenes, rezidivierendes oder metastasiertes Plattenepithelkarzinom des ÖsophagusChina
-
Sun Yat-sen UniversityZhejiang Cancer Hospital; Fudan University; Peking University Cancer Hospital... und andere MitarbeiterUnbekanntNasopharynxkarzinomChina
-
Actavis Inc.AbgeschlossenAktinische KeratoseVereinigte Staaten
-
The Netherlands Cancer InstituteAbgeschlossen
-
Melissa Pugliano-MauroNational Cancer Institute (NCI)RekrutierungKarzinom, PlattenepithelVereinigte Staaten
-
The Netherlands Cancer InstituteAbgeschlossen
-
Hong Kong Nasopharyngeal Cancer Study Group LimitedThe Hong Kong Anti-Cancer Society; hong Kong Cancer FundAbgeschlossen
-
Peking Union Medical College HospitalRekrutierungDarmkrebs | Darmkrebs | Chemotherapie-Effekt | PTC | Exon-MutationChina
-
Boston UniversityRekrutierungOberflächliches Basalzellkarzinom | Plattenepithelkarzinom in situVereinigte Staaten
-
The Cleveland ClinicNational Cancer Institute (NCI)BeendetAktinische Keratose | Organ- oder Gewebetransplantation; KomplikationenVereinigte Staaten