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Home > "C" Clinical Trials Conditions > Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer  Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer
Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer
Status: Recruiting
Sponsor(s): EORTC Breast Cancer Cooperative Group , EORTC New Drug Development Group,National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if capecitabine is more effective than vinorelbine in treating metastatic breast cancer. PURPOSE: Randomizedphase II/III trial to compare the effectiveness of capecitabine with that of vinorelbine in treating women who have metastatic breast cancer that has been previously treated with chemotherapy.
Details: OBJECTIVES: Phase II Study: - Compare the response rate in women with previously treated metastatic breast cancer treated with capecitabine vs vinorelbine. - Compare the duration of response in patients treated with these drugs. Phase III Study: - Compare overall and progression-free survival in patients treated with these drugs. - Compare time to treatment failure in patients treated with these drugs. - Compare overall safety of these drugs in these patients. - Compare quality of life and clinical benefit response in patients treated with these drugs. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and taxane resistance (refractory vs resistant vs sensitive). - Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive vinorelbine IV on days 1 and 8. Courses repeat every 21 days. - Arm II: Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days. In both arms, treatment continues in the absence of progression or unacceptable toxicity. If sufficient response rate is determined in phase II, the phase III study is initiated. - Phase III: Patients are randomized and receive treatment as in phase II. Quality of life is assessed prior to randomization, at weeks 3, 6, 9, 18, 24, and 30, and then every 12 weeks until disease progression. Clinical benefit response is assessed daily while patient is on study. Patients are followed every 6 weeks until disease progression and then every 12 weeks thereafter. PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for phase II of this study and a total of 406-452 patients (203-226 per treatment arm) will be accrued for phase III of this study within 18.5 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Metastatic disease - Prior treatment with taxanes in the metastatic, adjuvant, or neoadjuvant setting - Taxane-resistant disease allowed regardless of duration of prior therapy NOTE: Resistant disease defined as progression during or within 12 weeks after taxane therapy for metastatic disease or a disease-free interval of less than 12 months after neoadjuvant or adjuvant therapy with a taxane - Taxane-sensitive disease allowed if at least 4 prior courses were received NOTE: Sensitive disease defined as progression occurring more than 12 weeks after taxane therapy for metastatic disease or more than 12 months after neoadjuvant or adjuvant therapy with a taxane - Prior treatment with anthracyclines for metastatic disease or as adjuvant treatment OR medical contraindication to treatment with anthracyclines - At least one unidimensionally measurable lesion (phase II study) - No CNS metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - Karnofsky 70-100% 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 1.25 times upper limit of normal (ULN) - Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal - Creatinine clearance greater than 50 mL/min Cardiovascular - No symptomatic ventricular arrhythmias - No clinically significant congestive heart failure - No clinical or ECG evidence of myocardial infarction within the past 12 months - No significant coronary artery disease Other - Not pregnant or nursing - Fertile patients must use effective contraception - No prior malignancy within the past 5 years except contralateral breast cancer, nonmelanoma skin cancer, and adequately treated carcinoma in situ of the cervix - No known or prior sensitivity to fluoropyrimidines, including fluorouracil - No pre-existing grade 2 or greater neurotoxicity - No known malabsorption or upper gastrointestinal abnormalities that would affect absorption of study drug - No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent biologic therapy Chemotherapy - See Disease Characteristics - No more than 2 prior chemotherapy lines for metastatic disease - No prior capecitabine, vinca alkaloids, or continuous fluorouracil - No other concurrent chemotherapy Endocrine therapy - Prior hormonal therapy allowed - No concurrent hormonal therapy Radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - Bisphosphonate therapy for treatment and prevention of bony metastases allowed if initiated prior to study - No other concurrent investigational treatment - No concurrent brivudine with capecitabine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MartinePiccart-Gebhart, , Institut Jules Bordet
Western General Hospital *Recruiting*
Edinburgh, Scotland, EH4 2XU
United Kingdom
Recruiting Contact Person 44-777-3500
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-541-3111
Western Infirmary *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting Contact Person 44-330-4006
Algemeen Ziekenhuis Sint-Augustinus *Recruiting*
Wilrijk, , 2610
Belgium
Recruiting Contact Person 32-443-3011
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-821-3000
Institut Bergonie *Recruiting*
Bordeaux, , 33076
France
Recruiting Contact Person 33-556-333-333
Centre Henri Becquerel *Recruiting*
Rouen, , 76038
France
Recruiting Contact Person 33-232-08-2222
Weston Park Hospital *Recruiting*
Sheffield, England, S1O 2SJ
United Kingdom
Recruiting Contact Person 44-226-5000
Algemeen Ziekenhuis Middelheim *Recruiting*
Antwerp, , 2020
Belgium
Recruiting Contact Person 32-280-3111
Klinikum Nuernberg - Klinikum Sued *Recruiting*
Nurberg, , 90471
Germany
Recruiting Contact Person 49-398-2460
Institute of Oncology, Ljubljana *Recruiting*
LJUBLJANA, , Sl-1000
Slovenia
Recruiting Contact Person 386-323-063
Beatson Oncology Centre *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting Contact Person 44-141-211-1712
Additional Information:
Study ID Numbers: CDR0000258144; EORTC-16001O,IDBBC-EORTC-10001,EORTC-10001
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049660
Other Stage 4 Breast Cancer Studies:
1. Vaccine Therapy in Treating Patients With Metastatic Breast Cancer
2. Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer
3. Trastuzumab Plus Paclitaxel in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
4. Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer
5. Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Scotland Clinical Trials
Other Glasgow Clinical Trials
Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer
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