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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Cyclophosphamide
Fluorouracil
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014