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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01196455
• Other study ID #: MO18646
• Status: Recruiting
• Phase: Phase 2
• First received: August 31, 2010
• Last updated: September 7, 2010
• Start date: March 2006

Study information

• Verified date: August 2010
• Source: Croatian Cooperative Group for Clinical Research in Oncology
• Contact: Eduard Vrdoljak, PhD MD
• Phone: 00385-21-556-129
• Email: eduard.vrdoljak[@]st.htnet.hr
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastasis

Intervention

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

Locations

Country	Name	City	State
Croatia	Center of oncology	Split

Sponsors (2)

Lead Sponsor	Collaborator
Croatian Cooperative Group for Clinical Research in Oncology	Roche Pharma AG

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		average 5 years	Yes
Secondary	time to disease progression		average 5 years	Yes
Secondary	overall survival		average 5 years	Yes
Secondary	Toxicity		average 5 years	Yes