Mono Efficacy of Capecitabine (MoniCa)
October 5, 2011 updated by: German Breast Group
A Multicenter Phase II Study to Determine the Efficacy of Capecitabine as First Line Monochemotherapy in Patients With HER2 Negative, Medium-risk, Metastatic Breast Cancer
Study done in patients with metastatic breast cancer in order to determine the efficacy of capecitabine
Study Overview
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
Primary objective
To determine the time to disease progression in patients with HER2 negative metastatic breast cancer after 1st line monochemotherapy with capecitabine
Secondary objectives
- To determine the objective response rate
- To determine the duration of response
- To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks
- To evaluate the safety and toxicity of capecitabine
- To assess quality of life within 1 year after start of capecitabine treatment
- To determine overall survival
- To determine the objective response rate in male patients
- To evaluate QoL the modified Brunner Score (Appendix 7 )
Tertiary objective
To determine the DPD and Proteomics in serum
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hessen
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Frankfurt am Main, Hessen, Germany, 60590
- J. W. Goethe Universität, Frauenklinik
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
Capecitabine 2000 mg/m2 orally day 1-14 q day 22 until progression, unacceptable toxicity, patient's request or withdrawal from study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Any progression of disease or disease related death of a patient
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Any response (partial and complete) documented according to the WHO Criteria (s. App 6),
|
|
Time from complete or partial response until progression of disease or death due to any cause,
|
|
Any response (partial and complete) and stable disease of > 24 weeks duration documented according to the WHO Criteria (App. 6),
|
|
Any grade III/IV toxicity (NCI-CTC Version 2.0),
|
|
Premature treatment discontinuation,
|
|
Any dose reduction due to toxicity,
|
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Any death of a patient,
|
|
EORTC QoL and modified Brunner Score,
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Manfred Kaufmann, MD, Klinikum der J. W. Goethe Universität, Universitätsfrauenklinik
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
October 6, 2011
Last Update Submitted That Met QC Criteria
October 5, 2011
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GBG 39
- Eudract Number: 2005-000074-51
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.