Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer

September 7, 2010 updated by: Croatian Cooperative Group for Clinical Research in Oncology

Phase II Clinical Study of Capecitabine in Combination With Mitomycin C as First-Line Treatment in Patients With Metastatic Breast Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Drug: Capecitabine and Mitomycin C

Study Type

Interventional

Enrollment (Anticipated)

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

Croatia
- - Split, Croatia, 21000
    - Recruiting
    - Center of oncology
    - Contact:
      
      Eduard Vrdoljak, MD PhD
      
      Phone Number: 00385-21-556-129
      
      Email: eduard.vrdoljak@st.htnet.hr

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

Genders Eligible for Study

Female

Description

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)]

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: NA
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate Time Frame: average 5 years	average 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
time to disease progression Time Frame: average 5 years	average 5 years
overall survival Time Frame: average 5 years	average 5 years
Toxicity Time Frame: average 5 years	average 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Croatian Cooperative Group for Clinical Research in Oncology

Collaborators

Roche Pharma AG

Investigators

Principal Investigator: Eduard Vrdoljak, MD PhD, Clinical Hospital Split, Center of oncology, Croatia

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

March 1, 2006

Primary Completion (ANTICIPATED)

April 1, 2011

Study Registration Dates

First Submitted

August 31, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (ESTIMATE)

September 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)