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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2008 by Fudan University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Fudan University

ClinicalTrials.gov Identifier:

NCT00589901

First received: December 26, 2007

Last updated: April 17, 2008

Last verified: April 2008

History of Changes

Purpose

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	Intervention	Phase
Breast Cancer	Drug: capecitabine and cyclophosphamide	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Capecitabine

U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:

TTP (first treatment of this regimen to disease progression) [ Time Frame: every two cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

side effects [ Time Frame: all cycles ] [ Designated as safety issue: Yes ]
pharmacogenetic analysis [ Time Frame: collect blood samples before this therapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589901

Contacts

Contact: Zhonghua Wang, MD

8613918322628

zhonghuawang95@hotmail.com

Locations

China, Shanghai
Fudan University Cancer Hospital	Recruiting
Shanghai, Shanghai, China, +86200032
Sub-Investigator: Xichun Hu, MD, PhD

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator:

Zhonghua Wang, MD

Fudan University

More Information

Publications:

Fumoleau P, Largillier R, Clippe C, Dièras V, Orfeuvre H, Lesimple T, Culine S, Audhuy B, Serin D, Curé H, Vuillemin E, Morère 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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Aug 27.

Responsible Party:	Base of drug clinical trials, Fudan University Cancer Hospital, Fudan University Cancer Hospital
ClinicalTrials.gov Identifier:	NCT00589901 History of Changes
Other Study ID Numbers:	200507CX
Study First Received:	December 26, 2007
Last Updated:	April 17, 2008
Health Authority:	China: Ethics Committee

Keywords provided by Fudan University:

metastatic breast cancer
capecitabine
synergistic effect
chemotherapy

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Capecitabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 21, 2013

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