Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer
NCT ID: NCT01196455
Last Updated: 2010-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
39 participants
INTERVENTIONAL
2006-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Capecitabine and Mitomycin C
* Capecitabine 1000 mg/m2 twice-daily, administered orally on day 1-14, every three weeks
* Mitomycin C 8 mg/m2 i.v. bolus, on day 1, every three weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic breast cancer, having at least one target lesion according to the RECIST criteria. Bone metastases, leptomeningeal disease, ascites, pleural or pericardial effusions, inflammatory breast disease, lymphangitic spread or cystic lesions are not acceptable as target lesions. Target lesions must be ≥ 10 mm longest diameter measured in one dimension using spiral CT, or ≥ 20 mm longest diameter measured in one dimension using conventional techniques. In addition to the definitions pertaining to the target lesion(s) from the RECIST criteria above, the target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable).
* Age \> 18 years
* Signed informed consent obtained prior to initiation of any study-specific procedures or treatment
Exclusion Criteria
* Prior usage of capecitabine or mitomycin as adjuvant or neoadjuvant treatment
* Life expectancy \< 3 months
* Not-ambulatory or with an ECOG performance status \> 1
* Insufficient hematological, renal and hepatic functions:
* hemoglobin \< 8.0 g/dL
* absolute neutrophils count (ANC) \< 1.5 x 109/L
* platelet count \< 100 x 109/L
* serum creatinine \> 1.25 x N\*
* total bilirubin \> 2.0 x N\*
* ASAT and/or ALAT \> 2.5 x N\* (in case of liver metastases \> 5 x N\*)
* alkaline phosphatase \> 2.5 x N\* (in case of liver metastases \> 5 x N\*, in case of bone metastases \> 10 x N\*) \*N = upper limit of standard range
* Severe renal impairment \[creatinine clearance \< 30 mL/min (calculated according to cockcroft and Gault)\]
18 Years
FEMALE
No
Sponsors
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Roche Pharma AG
INDUSTRY
Croatian Cooperative Group for Clinical Research in Oncology
OTHER
Responsible Party
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Clinical Hospital Split, Center of oncology
Principal Investigators
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Eduard Vrdoljak, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Hospital Split, Center of oncology, Croatia
Locations
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Center of oncology
Split, , Croatia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MO18646
Identifier Type: -
Identifier Source: org_study_id