An All-Oral Combination of Capecitabine and Cyclophosphamide in Patients With Metastatic Breast Cancer (MBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00589901
Recruitment Status : Unknown
Verified April 2008 by Fudan University.
Recruitment status was:  Recruiting
First Posted : January 10, 2008
Last Update Posted : April 18, 2008
Information provided by:
Fudan University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: capecitabine and cyclophosphamide Phase 2

Detailed Description:
Xeloda (capecitabine) is converted to 5-fluorouracil by thymidine phosphorylase, and cyclophosphamide is capable of upregulating the expression of thymidine phosphorylase suggesting a synergistic effect.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of an All-Oral Combination of Capecitabine (X) and Cyclophosphamide (C) in Patients With Anthracycline- and Taxane-Pretreated Metastatic Breast Cancer
Study Start Date : August 2006
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
phase II trial of capecitabine and cyclophosphamide in the management of metastatic breast cancer
Drug: capecitabine and cyclophosphamide

capecitabine 1000 mg/m2 oral Bid d1-14

cyclophosphamide 65 mg/m2 oral Qd d1-14

Other Name: Xeloda

Primary Outcome Measures :
  1. TTP (first treatment of this regimen to disease progression) [ Time Frame: every two cycles ]

Secondary Outcome Measures :
  1. side effects [ Time Frame: all cycles ]
  2. pharmacogenetic analysis [ Time Frame: collect blood samples before this therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00589901

Contact: Zhonghua Wang, MD 8613918322628

China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, +86200032
Sub-Investigator: Xichun Hu, MD, PhD         
Sponsors and Collaborators
Fudan University
Principal Investigator: Zhonghua Wang, MD Fudan University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Base of drug clinical trials, Fudan University Cancer Hospital, Fudan University Cancer Hospital Identifier: NCT00589901     History of Changes
Other Study ID Numbers: 200507CX
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: April 18, 2008
Last Verified: April 2008

Keywords provided by Fudan University:
metastatic breast cancer
synergistic effect

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic