- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00006088
Vinorelbine in Treating Patients With Metastatic or Advanced Solid Tumors
A Phase I Absolute Bioavailability Study of Oral NAVELBINE (Vinorelbine Tartrate) in Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase I trial to compare the effectiveness of two different regimens of vinorelbine in treating patients who have metastatic or advanced solid tumors.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES: I. Compare the pharmacokinetic profiles of vinorelbine administered intravenously on day 1 and orally on day 8 vs the reverse order in patients with metastatic or advanced solid tumors. II. Determine the intersubject variability in the pharmacokinetics of oral vinorelbine. III. Compare the safety profiles of oral vs intravenous vinorelbine in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive vinorelbine IV over 20 minutes on day 1 and oral vinorelbine on day 8. Arm II: Patients receive oral vinorelbine on day 1 and vinorelbine IV over 20 minutes on day 8. Treatment continues in both arms in the absence of unacceptable toxicity or disease progression. Patients are followed for 28 days.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Studientyp
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Florida
-
Tampa, Florida, Vereinigte Staaten, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS: Histologically confirmed metastatic or advanced solid tumor that will potentially benefit from single agent vinorelbine No known CNS metastases unless successfully treated with excision or radiotherapy and stable for at least 6 months prior to study
PATIENT CHARACTERISTICS: Age: 18-75 Performance status: Not specified Life expectancy: Greater than 3 months Hematopoietic: Hemoglobin at least 9 g/dL (at least 3 weeks since last transfusion) Platelet count at least 75,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Transaminases no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN No unstable or uncontrolled hypercalcemia Cardiovascular: No venous access problems that would preclude blood sampling No symptomatic class II-IV congestive heart failure No significant ventricular arrhythmia requiring drug control No myocardial infarction within the past 6 months No uncontrolled cardiac disease or unstable angina No recurrent thromboembolic events No unstable or uncontrolled arterial hypertension Pulmonary: No history of recurrent aspiration pneumonitis or aspiration pneumonia No severe respiratory insufficiency, defined by oxygen partial pressure less than 60 mm Hg on room air and requirement for chronic oxygen therapy Gastrointestinal: See Surgery No active gastrointestinal disease or disorder that alters gastrointestinal motility or absorption No lack of integrity of the gastrointestinal tract No unstable or uncontrolled diarrhea or peptic ulcer disease Other: Able to receive IV and oral regimens Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for at least 2 weeks before, during, and for at least 9 days after study No preexisting peripheral neuropathy greater than grade 1 No active infection within the past 2 weeks No fever (temperature at least 37.5 degrees C) or other symptoms of possible infection within 10 days after completing antimicrobial treatment No psychological, familial, or sociological condition that would preclude study No unstable or uncontrolled preexisting medical condition (e.g., diabetes, alcohol withdrawal)
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior packed red blood cell transfusion At least 1 week since prior platelet transfusion or hematopoietic growth factors No concurrent growth factors earlier than 24 hours after study drug Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered No other concurrent antineoplastic agents Endocrine therapy: At least 3 weeks since prior hormonal therapy and recovered Concurrent megestrol allowed No other concurrent hormonal therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Prior or concurrent palliative radiotherapy to peripheral bone lesion, spinal cord compression, or imminent fracture allowed only if less than 10% of bone marrow involved Surgery: No prior significant surgical resection of the stomach or small bowel At least 2 weeks since prior surgery Other: No other concurrent experimental or anticancer drugs or devices At least 1 week since prior products or drugs known to induce or inhibit the enzymatic activity of vinorelbine (e.g., antihistamines, phenobarbital, meprobamate, some antiepileptics, or grapefruit juice) No concurrent products or drugs known to induce or inhibit the enzymatic activity of vinorelbine No concurrent opiates or laxatives
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Daniel M. Sullivan, MD, H. Lee Moffitt Cancer Center and Research Institute
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
Andere Studien-ID-Nummern
- CDR0000068080
- MCC-11982
- GW-VIN10003
- NCI-G00-1826
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 Vinorelbintartrat
-
Mast Therapeutics, Inc.Worldwide Clinical Trials; Synteract, Inc.; Thywill Latam Solutions SRL; OCASA Soluciones...AbgeschlossenBrustkrebs | Nicht-kleinzelligem Lungenkrebs | Non-Hodgkins-LymphomArgentinien
-
The First Affiliated Hospital with Nanjing Medical...Rekrutierung
-
The Netherlands Cancer InstituteEli Lilly and Company; Universitaire Ziekenhuizen KU Leuven; European Organisation... und andere MitarbeiterUnbekannt
-
Mario Negri Institute for Pharmacological ResearchBeendetDreifach negativer BrustkrebsSpanien, Italien, Portugal
-
Zhiyong YuNoch keine RekrutierungPathologische RestkrebszellenChina
-
Vaderis Therapeutics AGRekrutierungHereditäre hämorrhagische Teleangiektasie (HHT)Vereinigte Staaten, Spanien, Frankreich, Belgien, Niederlande, Italien
-
Qilu Pharmaceutical Co., Ltd.Noch keine Rekrutierung
-
University of NebraskaNational Cancer Institute (NCI)AbgeschlossenRezidivierendes nicht-kleinzelliges Lungenkarzinom | Nicht-kleinzelliger Lungenkrebs im Stadium IVVereinigte Staaten
-
RemeGen Co., Ltd.Rekrutierung
-
Amicus TherapeuticsAbgeschlossenGaucher-Krankheit | Gaucher-Krankheit, Typ 1 | Gaucher-Krankheit Typ 1Vereinigte Staaten