Status:
COMPLETED
Mono Efficacy of Capecitabine (MoniCa)
Lead Sponsor:
GBG Forschungs GmbH
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Study done in patients with metastatic breast cancer in order to determine the efficacy of capecitabine
Detailed Description
Study design: Prospective, open phase II trial Treatment: Capecitabine 2000 mg/m² orally day 1-14 q day 22 until progression, unacceptable toxicity, patient's request or withdrawal from study Prim...
Eligibility Criteria
Inclusion
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
- Histologically confirmed carcinoma of the breast.
- Negative for HER2-overexpression of the primary and/or metastatic tumour tissue detected by immunohistochemistry (DAKO 0-2) or genamplification detected by FISH.
- Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone.
- The following previous systemic treatment are eligible:
- adjuvant chemotherapy (except if capecitabine was included) adjuvant endocrine therapy palliative endocrine treatments treatment with bisphosphonates (adjuvant and/or palliative) treatment with immunotherapies (adjuvant and/or palliative)
- Patients must have either measurable or nonmeasurable target lesions according to the WHO criteria (see Appendix 5).
- At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease.
- Complete radiology and tumor measurement work up within 4 weeks prior to registration.
- Karnofsky performance status evaluation \> or = 60%
- Age \>18 years
- WBC \> or = 3000 cells/microl, platelet count \> or = 100,000 cells/microl.
- Bilirubin \< or = 2x the upper limit of normal for the institution (ULN); elevation of transaminases and alkaline phosphatase \< 2.5x ULN or \<5x ULN for patients with liver metastases.
- Creatinine \< or = 1,25 x upper normal value or creatinin-clearance \> 50 ml/min (according to Cockroft Gault).
- If of childbearing potential, negative pregnancy test. In addition the patient has to agree to use an effective method to avoid pregnancy for the duration of the study.
- Female and male patients
Exclusion
- Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
- Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued.
- Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and discontinuation of all steroids.
- Life expectancy of less than 3 months.
- Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including AIDS and serious active infection).
- History of other malignancy within the last 5 years which could affect the diagnosis or assessment of metastatic breast cancer.
- Patients with indication for polychemotherapy.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
- Treatment with sorivudine or derivates e.g. brivudin.
- Pregnant or nursing women.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00196820
Start Date
July 1 2005
End Date
December 1 2008
Last Update
October 6 2011
Active Locations (1)
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1
J. W. Goethe Universität, Frauenklinik
Frankfurt am Main, Hesse, Germany, 60590