NCT00589901

Brief Summary

The primary objective of this study is to evaluate the time to progression. Secondary objectives are safety, OS and pharmacogenetic analysis. Sixty patients will be enrolled into this study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 18, 2008

Status Verified

April 1, 2008

Enrollment Period

2.3 years

First QC Date

December 26, 2007

Last Update Submit

April 17, 2008

Conditions

Breast Cancer

Keywords

metastatic breast cancercapecitabinesynergistic effectchemotherapy

Outcome Measures

Primary Outcomes (1)

  • TTP (first treatment of this regimen to disease progression)

    every two cycles

Secondary Outcomes (2)

  • side effects

    all cycles

  • pharmacogenetic analysis

    collect blood samples before this therapy

Study Arms (1)

A

EXPERIMENTAL

phase II trial of capecitabine and cyclophosphamide in the management of metastatic breast cancer

Drug: capecitabine and cyclophosphamide

Interventions

capecitabine and cyclophosphamideDRUG

capecitabine 1000 mg/m2 oral Bid d1-14 cyclophosphamide 65 mg/m2 oral Qd d1-14

Also known as: Xeloda
A

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed breast cancer
  • Anthracycline and taxane pretreated metastatic breast cancer
  • Have not been previously treated with capecitabine
  • ECOG performance status of ≤ 1
  • Are female and ≥ 18 and ≤ 70 years of age
  • Have at least one target lesion according to the RECIST criteria

You may not qualify if:

  • Pregnant or lactating women
  • ECOG ≥ 2
  • Have been treated with capecitabine
  • Evidence of CNS metastasis
  • History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
  • Abnormal laboratory values: hemoglobin \< 8.0 g/dl, neutrophils \< 1.5×10\^9/L, platelets \< 100×10\^9/L, serum creatinine \> upper limit of normal (ULN), serum bilirubin \> ULN, ALT and AST \> 5×ULN, AKP \> 5×ULN
  • Serious uncontrolled intercurrent infection
  • Life expectancy of less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, +86200032, China

RECRUITING

Related Publications (3)

  • Fumoleau P, Largillier R, Clippe C, Dieras V, Orfeuvre H, Lesimple T, Culine S, Audhuy B, Serin D, Cure H, Vuillemin E, Morere JF, Montestruc F, Mouri Z, Namer M. Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer. 2004 Mar;40(4):536-42. doi: 10.1016/j.ejca.2003.11.007.

    PMID: 14962720BACKGROUND

  • Endo M, Shinbori N, Fukase Y, Sawada N, Ishikawa T, Ishitsuka H, Tanaka Y. Induction of thymidine phosphorylase expression and enhancement of efficacy of capecitabine or 5'-deoxy-5-fluorouridine by cyclophosphamide in mammary tumor models. Int J Cancer. 1999 Sep 24;83(1):127-34. doi: 10.1002/(sici)1097-0215(19990924)83:13.0.co;2-6.

    PMID: 10449619BACKGROUND

  • Wang Z, Lu J, Leaw S, Hong X, Wang J, Shao Z, Hu X. An all-oral combination of metronomic cyclophosphamide plus capecitabine in patients with anthracycline- and taxane-pretreated metastatic breast cancer: a phase II study. Cancer Chemother Pharmacol. 2012 Feb;69(2):515-22. doi: 10.1007/s00280-011-1728-3. Epub 2011 Aug 27.

    PMID: 21874317DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CapecitabineCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Zhonghua Wang, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhonghua Wang, MD

CONTACT

8613918322628zhonghuawang95@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 10, 2008

Study Start

August 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 18, 2008

Record last verified: 2008-04

Locations

CN(1)