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

December 26, 2007
April 17, 2008
August 2006
December 2008   (final data collection date for primary outcome measure)
TTP (first treatment of this regimen to disease progression) [ Time Frame: every two cycles ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00589901 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
An All-Oral Combination of Capecitabine and Cyclophosphamide in Patients With Metastatic Breast Cancer (MBC)
Phase II Study of an All-Oral Combination of Capecitabine (X) and Cyclophosphamide (C) in Patients With Anthracycline- and Taxane-Pretreated Metastatic Breast Cancer

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Experimental: A
phase II trial of capecitabine and cyclophosphamide in the management of metastatic breast cancer
Intervention: Drug: capecitabine and cyclophosphamide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact: Zhonghua Wang, MD 8613918322628 zhonghuawang95@hotmail.com
China
 
NCT00589901
200507CX
No
Base of drug clinical trials, Fudan University Cancer Hospital, Fudan University Cancer Hospital
Fudan University
Not Provided
Principal Investigator: Zhonghua Wang, MD Fudan University
Fudan University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP