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Sponsored by: |
Fudan University |
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Information provided by: | Fudan University |
ClinicalTrials.gov Identifier: | NCT00589901 |
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 |
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Breast Cancer |
Drug: capecitabine and cyclophosphamide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
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 |
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A: Experimental
phase II trial of capecitabine and cyclophosphamide in the management of metastatic breast cancer
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Drug: capecitabine and cyclophosphamide
capecitabine 1000 mg/m2 oral Bid d1-14 cyclophosphamide 65 mg/m2 oral Qd d1-14
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Zhonghua Wang, MD | 8613918322628 | zhonghuawang95@hotmail.com |
China | |
Fudan University Cancer Hospital | Recruiting |
Shanghai, China, +86200032 | |
Sub-Investigator: Xichun Hu, MD, PhD |
Principal Investigator: | Zhonghua Wang, MD | Fudan University Cancer Hospital |
Responsible Party: | Fudan University Cancer Hospital ( Base of drug clinical trials, Fudan University Cancer Hospital ) |
Study ID Numbers: | 200507CX |
Study First Received: | December 26, 2007 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00589901 History of Changes |
Health Authority: | China: Ethics Committee |
metastatic breast cancer capecitabine synergistic effect chemotherapy |
Antimetabolites Capecitabine Immunologic Factors Skin Diseases Breast Neoplasms Antineoplastic Agents, Alkylating |
Cyclophosphamide Antirheumatic Agents Alkylating Agents Immunosuppressive Agents Taxane Breast Diseases |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |