- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00003730
Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer
A Multicenter Randomized Trial, With Direct Individual Benefit, to Determine the Optimal Circadian Time of Vinorelbine Administration Combined With Chronomodulated Infusion of 5-Fluorouracil in Previously Treated Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized clinical trial to study the effectiveness of vinorelbine plus fluorouracil in treating women who have metastatic breast cancer that has been previously treated with at least one regimen of chemotherapy.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
- Determine the least toxic time of vinorelbine administration when combined with chronomodulated fluorouracil in women with previously treated metastatic breast cancer.
- Determine the toxic effects and dose intensities of each drug in these women.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior chemotherapy (second line vs third line) and participating center. Patients are randomized to 1 of 8 vinorelbine dosing times (0000, 0300, 0600, 0900, 1200, 1500, 1800, or 2100).
Patients receive vinorelbine IV over 20 minutes on days 1 and 6 and fluorouracil IV over 12 hours according to a chronomodulated delivery rate (2200 to 1000 with a maximum dose at 0400) on days 1-4. Treatment repeats every 3 weeks for at least 3 courses in the absence of unacceptable toxicity.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A minimum of 80 patients (10 per dosing time) will be accrued for this study.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Antwerpen, Belgien, 2010
- VZW Monica Campus Eeuwfeestkliniek
-
Liege, Belgien, B-4000
- CHU Liege - Domaine Universitaire du Sart Tilman
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Liege, Belgien, B 4000
- C.H.C - Asbl
-
-
-
-
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Clermont-Ferrand, Frankrike, 63011
- Centre Jean Perrin
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Dijon, Frankrike, 21079
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
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Levallois-Perret, Frankrike, 92300
- Hopital Perpetuel Secours
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Limoges, Frankrike, 87042
- Centre Hospital Regional Universitaire de Limoges
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Paris, Frankrike, 75475
- Hôpital Saint-Louis
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Saint Cloud, Frankrike, 92211
- Centre René Huguenin
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Saint Etienne, Frankrike, 42055
- Hopital Bellevue
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Villejuif, Frankrike, 94804
- Hopital Paul Brousse
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-
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Crete
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Iraklion (Heraklion), Crete, Grekland, 71110
- University Hospital of Heraklion
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-
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-
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Candiolo (Turin), Italien, 10180
- Istituto per la Ricerca e Cura del Cancro
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Milano (Milan), Italien, 20153
- Ospedale San Carlo Borromeo
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Orbassano, (Torino), Italien, 10043
- Azienda Ospedale S. Luigi - Universita Di Turin
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Pavia, Italien, I-27100
- Fondazione Salvatore Maugeri
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Rome, Italien, 00161
- Istituti Fisioterapici Ospitalieri - Roma
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic breast cancer
- At least 1 line of prior chemotherapy for metastatic disease (adjuvant or neoadjuvant chemotherapy is considered first line if completed less than one year prior to palliative chemotherapy)
- No cerebral metastases
Hormonal receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Not specified
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm ^3
Hepatic:
- Bilirubin no greater than 2.5 times upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.58 mg/dL
Cardiovascular:
- No clinically significant cardiac insufficiency or ischemic disease
Pulmonary:
- No bronchoconstriction other than pulmonary lymphangitis
Other:
- No serious chronic disease
- No bowel obstruction
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
- No concurrent prophylactic growth factor
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No prior high-dose chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy
- No concurrent steroid therapy except in an emergency
Radiotherapy:
- At least 4 weeks since prior radiotherapy (for primary tumor or axillary or mammary chain treatment only)
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent antitumor therapy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
Samarbetspartners och utredare
Utredare
- Studiestol: Bruno Coudert, MD, Centre Georges Francois Leclerc
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hudsjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Bröstsjukdomar
- Bröstneoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Fluorouracil
- Vinorelbin
Andra studie-ID-nummer
- EORTC-05971
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