Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Croatian Cooperative Group for Clinical Research in Oncology.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Croatian Cooperative Group for Clinical Research in Oncology
Collaborator:
Roche Pharma AG
Information provided by:
Croatian Cooperative Group for Clinical Research in Oncology
ClinicalTrials.gov Identifier:
NCT01196455
First received: August 31, 2010
Last updated: September 7, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Metastasis |
Drug: Capecitabine and Mitomycin C |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Clinical Study of Capecitabine in Combination With Mitomycin C as First-Line Treatment in Patients With Metastatic Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Croatian Cooperative Group for Clinical Research in Oncology:
Primary Outcome Measures:
- Response rate [ Time Frame: average 5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- time to disease progression [ Time Frame: average 5 years ] [ Designated as safety issue: Yes ]
- overall survival [ Time Frame: average 5 years ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: average 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 39 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: 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
- Capecitabine (Xeloda)
- Mitomycin C (Mutamycin)
Other Names:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)]
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196455
Contacts
| Contact: Eduard Vrdoljak, PhD MD | 00385-21-556-129 | eduard.vrdoljak@st.htnet.hr |
Locations
| Croatia | |
| Center of oncology | Recruiting |
| Split, Croatia, 21000 | |
| Contact: Eduard Vrdoljak, MD PhD 00385-21-556-129 eduard.vrdoljak@st.htnet.hr | |
Sponsors and Collaborators
Croatian Cooperative Group for Clinical Research in Oncology
Roche Pharma AG
Investigators
| Principal Investigator: | Eduard Vrdoljak, MD PhD | Clinical Hospital Split, Center of oncology, Croatia |
More Information
No publications provided
| Responsible Party: | Prof. dr. sc. Eduard Vrdoljak, Clinical Hospital Split, Center of oncology |
| ClinicalTrials.gov Identifier: | NCT01196455 History of Changes |
| Other Study ID Numbers: | MO18646 |
| Study First Received: | August 31, 2010 |
| Last Updated: | September 7, 2010 |
| Health Authority: | Croatia: Ethics Committee |
Keywords provided by Croatian Cooperative Group for Clinical Research in Oncology:
|
Metastatic breast cancer patients |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasm Metastasis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes Mitomycins Mitomycin Capecitabine Fluorouracil Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013