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Home > "V" Clinical Trials Conditions > Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer  Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer
Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): EORTC Chronotherapy Study Group ,
Synopsis: 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: Randomizedclinical 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrunoCoudert, , Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc *Recruiting*
Dijon, , 21079
France
Recruiting Contact Person 33-380-73-7500
Hopital Perpetuel Secours *Recruiting*
Levallois-Perret, , 92300
France
Recruiting Contact Person 33-47-59-59-59
University Hospital of Heraklion *Recruiting*
Iraklion (Heraklion), Crete, 71110
Greece
Recruiting Contact Person 81-392750
Istituti Fisioterapici Ospitalieri - Roma *Recruiting*
Rome, , 00161
Italy
Recruiting Contact Person 39-6-49852214
Ospedale San Carlo Borromeo *Recruiting*
Milano (Milan), , 20153
Italy
Recruiting Contact Person 39-402-21-4009
CHU Liege - Domaine Universitaire du Sart Tilman *Recruiting*
LIEGE, , B-4000
Belgium
Recruiting Contact Person 32-366-7111
VZW Monica Campus Eeuwfeestkliniek *Recruiting*
Antwerpen, , 2010
Belgium
Recruiting Contact Person 31-3-240-20-20
Istituto per la Ricerca e Cura del Cancro *Recruiting*
Candiolo (Turin), , 10180
Italy
Recruiting Contact Person 39-560-0848
Centre Hospital Regional Universitaire de Limoges *Recruiting*
Limoges, , 87042
France
Recruiting Contact Person 33-1424-94-949
C.H.C - Asbl *Recruiting*
LIEGE, , B 4000
Belgium
Recruiting Contact Person 32-224-8111
Hopital Bellevue *Recruiting*
Saint-Etienne, , 42055
France
Recruiting Contact Person 33-477-12-7770
Hopital Saint-Louis *Recruiting*
Paris, , 75475
France
Recruiting Contact Person 33-142-49-4949
Centre Jean Perrin *Recruiting*
Clermont-Ferrand, , 63011
France
Recruiting Contact Person 33-473-27-8080
Fondazione Salvatore Maugeri *Recruiting*
Pavia, , I-27100
Italy
Recruiting Contact Person 39 5921
Hopital Paul Brousse *Recruiting*
Villejuif, , 94804
France
Recruiting Contact Person 33-145-59-3000
Centre Rene Huguenin *Recruiting*
Saint Cloud, , 92211
France
Recruiting Contact Person 33-147-44-1501
Azienda Ospedale S. Luigi - Universita Di Torino *Recruiting*
Orbassano, (Torino), , 10043
Italy
Recruiting Contact Person 39-11-902-6511
Additional Information:
Study ID Numbers: CDR0000066843; EORTC-05971
Study Start Date:
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003730
Other Recurrent Breast Cancer Studies:
1. Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer
2. Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer
3. Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer
4. Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer
5. Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
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Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer
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