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
Sponsor:
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
  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
    Other Names:
    • Capecitabine (Xeloda)
    • Mitomycin C (Mutamycin)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Mitomycins
Mitomycin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 02, 2014