An All-Oral Combination of Capecitabine and Cyclophosphamide in Patients With Metastatic Breast Cancer (MBC)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
capecitabine and cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring metastatic breast cancer, capecitabine, synergistic effect, chemotherapy
Eligibility 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
Sites / Locations
- Fudan University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
phase II trial of capecitabine and cyclophosphamide in the management of metastatic breast cancer
Outcomes
Primary Outcome Measures
TTP (first treatment of this regimen to disease progression)
Secondary Outcome Measures
side effects
pharmacogenetic analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00589901
Brief Title
An All-Oral Combination of Capecitabine and Cyclophosphamide in Patients With Metastatic Breast Cancer (MBC)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
metastatic breast cancer, capecitabine, synergistic effect, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
phase II trial of capecitabine and cyclophosphamide in the management of metastatic breast cancer
Intervention Type
Drug
Intervention Name(s)
capecitabine and cyclophosphamide
Other Intervention Name(s)
Xeloda
Intervention Description
capecitabine 1000 mg/m2 oral Bid d1-14
cyclophosphamide 65 mg/m2 oral Qd d1-14
Primary Outcome Measure Information:
Title
TTP (first treatment of this regimen to disease progression)
Time Frame
every two cycles
Secondary Outcome Measure Information:
Title
side effects
Time Frame
all cycles
Title
pharmacogenetic analysis
Time Frame
collect blood samples before this therapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhonghua Wang, MD
Phone
8613918322628
Email
zhonghuawang95@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhonghua Wang, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
+86200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xichun Hu, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
14962720
Citation
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.
Results Reference
background
PubMed Identifier
10449619
Citation
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.
Results Reference
background
PubMed Identifier
21874317
Citation
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.
Results Reference
derived
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An All-Oral Combination of Capecitabine and Cyclophosphamide in Patients With Metastatic Breast Cancer (MBC)
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