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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00589901
• Other study ID #: 200507CX
• Status: Unknown status
• Phase: Phase 2
• First received: December 26, 2007
• Last updated: April 17, 2008
• Start date: August 2006
• Est. completion date: December 2008

Study information

• Verified date: April 2008
• Source: Fudan University
• Contact: Zhonghua Wang, MD
• Phone: 8613918322628
• Email: zhonghuawang95[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• capecitabine and cyclophosphamide
capecitabine 1000 mg/m2 oral Bid d1-14 cyclophosphamide 65 mg/m2 oral Qd d1-14

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TTP (first treatment of this regimen to disease progression)		every two cycles
Secondary	side effects		all cycles
Secondary	pharmacogenetic analysis		collect blood samples before this therapy