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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003730 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: fluorouracil Drug: vinorelbine tartrate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 80 |
| Study Start Date: | December 1998 |
OBJECTIVES:
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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormonal receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Belgium | |
| VZW Monica Campus Eeuwfeestkliniek | |
| Antwerpen, Belgium, 2010 | |
| C.H.C - Asbl | |
| Liege, Belgium, B 4000 | |
| CHU Liege - Domaine Universitaire du Sart Tilman | |
| Liege, Belgium, B-4000 | |
| France | |
| Centre Jean Perrin | |
| Clermont-Ferrand, France, 63011 | |
| Centre de Lutte Contre le Cancer Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| Hopital Perpetuel Secours | |
| Levallois-Perret, France, 92300 | |
| Centre Hospital Regional Universitaire de Limoges | |
| Limoges, France, 87042 | |
| Hopital Saint-Louis | |
| Paris, France, 75475 | |
| Centre Rene Huguenin | |
| Saint Cloud, France, 92211 | |
| Hopital Bellevue | |
| Saint Etienne, France, 42055 | |
| Hopital Paul Brousse | |
| Villejuif, France, 94804 | |
| Greece | |
| University Hospital of Heraklion | |
| Iraklion (Heraklion), Crete, Greece, 71110 | |
| Italy | |
| Istituto per la Ricerca e Cura del Cancro | |
| Candiolo (Turin), Italy, 10180 | |
| Ospedale San Carlo Borromeo | |
| Milano (Milan), Italy, 20153 | |
| Azienda Ospedale S. Luigi - Universita Di Turin | |
| Orbassano, (Torino), Italy, 10043 | |
| Fondazione Salvatore Maugeri | |
| Pavia, Italy, I-27100 | |
| Istituti Fisioterapici Ospitalieri - Roma | |
| Rome, Italy, 00161 | |
| Investigator: | Bruno Coudert, MD | Centre de Lutte Contre le Cancer Georges-Francois Leclerc |
More Information
| ClinicalTrials.gov Identifier: | NCT00003730 History of Changes |
| Other Study ID Numbers: | CDR0000066843, EORTC-05971 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 26, 2011 |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fluorouracil Vinorelbine Vinblastine Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |