Mono Efficacy of Capecitabine (MoniCa)

NCT00196820 | Completed Phase 2 DMC

• 2 other identifiers: GBG 39Eudract Number: 2005-000074-51
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Study done in patients with metastatic breast cancer in order to determine the efficacy of capecitabine

Conditions

Breast Cancer

Keywords

Metastatic breast cancer; HER2 negative, medium-risk, metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• Any progression of disease or disease related death of a patient

Secondary Outcomes (8)

• Any response (partial and complete) documented according to the WHO Criteria (s. App 6),

• Time from complete or partial response until progression of disease or death due to any cause,

• Any response (partial and complete) and stable disease of > 24 weeks duration documented according to the WHO Criteria (App. 6),

• Any grade III/IV toxicity (NCI-CTC Version 2.0),

• Premature treatment discontinuation,

Study Arms (1)

A

EXPERIMENTAL

Capecitabine 2000 mg/m2 orally day 1-14 q day 22 until progression, unacceptable toxicity, patient's request or withdrawal from study

Drug: Capecitabine

Interventions

Capecitabine DRUG

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
• Histologically confirmed carcinoma of the breast.
• Negative for HER2-overexpression of the primary and/or metastatic tumour tissue detected by immunohistochemistry (DAKO 0-2) or genamplification detected by FISH.
• Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone.
• The following previous systemic treatment are eligible:
• adjuvant chemotherapy (except if capecitabine was included) adjuvant endocrine therapy palliative endocrine treatments treatment with bisphosphonates (adjuvant and/or palliative) treatment with immunotherapies (adjuvant and/or palliative)
• Patients must have either measurable or nonmeasurable target lesions according to the WHO criteria (see Appendix 5).
• At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease.
• Complete radiology and tumor measurement work up within 4 weeks prior to registration.
• Karnofsky performance status evaluation \> or = 60%
• Age \>18 years
• WBC \> or = 3000 cells/microl, platelet count \> or = 100,000 cells/microl.
• Bilirubin \< or = 2x the upper limit of normal for the institution (ULN); elevation of transaminases and alkaline phosphatase \< 2.5x ULN or \<5x ULN for patients with liver metastases.
• Creatinine \< or = 1,25 x upper normal value or creatinin-clearance \> 50 ml/min (according to Cockroft Gault).
• If of childbearing potential, negative pregnancy test. In addition the patient has to agree to use an effective method to avoid pregnancy for the duration of the study.

You may not qualify if:

• Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
• Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued.
• Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and discontinuation of all steroids.
• Life expectancy of less than 3 months.
• Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including AIDS and serious active infection).
• History of other malignancy within the last 5 years which could affect the diagnosis or assessment of metastatic breast cancer.
• Patients with indication for polychemotherapy.
• Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
• Treatment with sorivudine or derivates e.g. brivudin.
• Pregnant or nursing women.

Sponsors & Collaborators

• GBG Forschungs GmbH: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

J. W. Goethe Universität, Frauenklinik

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Links

• Click here for more information about this study: MoniCa Study

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Manfred Kaufmann, MD

  Klinikum der J. W. Goethe Universität, Universitätsfrauenklinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2005
• Study Completion: December 1, 2008
• Last Updated: October 6, 2011

Record last verified: 2008-05

Locations

DE (1)