Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer
Primary Purpose
Breast Cancer, Metastasis
Status
Unknown status
Phase
Phase 2
Locations
Croatia
Study Type
Interventional
Intervention
Capecitabine and Mitomycin C
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Metastatic breast cancer patients
Eligibility Criteria
Inclusion Criteria:
- Histologically/cytologically confirmed breast cancer
- 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 cytotoxic chemotherapy or active/passive immunotherapy for metastatic breast disease
- 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)]
Sites / Locations
- Center of oncologyRecruiting
Outcomes
Primary Outcome Measures
Response rate
Secondary Outcome Measures
time to disease progression
overall survival
Toxicity
Full Information
NCT ID
NCT01196455
First Posted
August 31, 2010
Last Updated
September 7, 2010
Sponsor
Croatian Cooperative Group for Clinical Research in Oncology
Collaborators
Roche Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT01196455
Brief Title
Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer
Official Title
Phase II Clinical Study of Capecitabine in Combination With Mitomycin C as First-Line Treatment in Patients With Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Croatian Cooperative Group for Clinical Research in Oncology
Collaborators
Roche Pharma AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open-label, non-comparative efficacy and safety study of Capecitabine and Mitomycin C as first-line treatment in patients with previously untreated metastatic breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Metastasis
Keywords
Metastatic breast cancer patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Capecitabine and Mitomycin C
Other Intervention Name(s)
Capecitabine (Xeloda), Mitomycin C (Mutamycin)
Intervention Description
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
Primary Outcome Measure Information:
Title
Response rate
Time Frame
average 5 years
Secondary Outcome Measure Information:
Title
time to disease progression
Time Frame
average 5 years
Title
overall survival
Time Frame
average 5 years
Title
Toxicity
Time Frame
average 5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically/cytologically confirmed breast cancer
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 cytotoxic chemotherapy or active/passive immunotherapy for metastatic breast disease
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)]
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduard Vrdoljak, PhD MD
Phone
00385-21-556-129
Email
eduard.vrdoljak@st.htnet.hr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduard Vrdoljak, MD PhD
Organizational Affiliation
Clinical Hospital Split, Center of oncology, Croatia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of oncology
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduard Vrdoljak, MD PhD
Phone
00385-21-556-129
Email
eduard.vrdoljak@st.htnet.hr
12. IPD Sharing Statement
Learn more about this trial
Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer
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