Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)

This study has been completed.
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00629148
First received: February 26, 2008
Last updated: July 6, 2011
Last verified: June 2011
  Purpose

The primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.


Condition Intervention Phase
Breast Cancer
Metastasis, Neoplasm
Drug: Vinorelbine and Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • PFS(progression-free survival,defined as the time period between randomization and disease progress or death) and TTF (time to treatment failure, defined as all discontinuations for any cause) [ Time Frame: Every two cycles (3 weeks per cycle) and during the follow up time, until disease progression event occurs. ] [ Designated as safety issue: Yes ]
    PFS was assessed every two cycles (3 weeks per cycle)and during the follow up time, by serum tumor markers, physical examination and image examination, until disease progression event occurs. If a patient has the sign or hint of disease progression, then the lab examination, physical examination or image examination could be taken at any time.


Secondary Outcome Measures:
  • Safety, QOL(quality of life) [ Time Frame: Safety and QOL were assessed every cycle and during the follow up time, until 28 days after the last cycle. ] [ Designated as safety issue: Yes ]
    Safety and QOL were assessed every cycle(3 weeks per cycle) and during the follow up time, until 28 days after the last cycle.

  • TTP(time to progression) and OS (overall survival) [ Time Frame: TTP and OS were assessed every cycle and during the follow up time, until the event occurs. ] [ Designated as safety issue: Yes ]
    TTP and OS were assessed every cycle(3 weeks per cycle) and during the follow up time, until the event occurs.


Enrollment: 60
Study Start Date: August 2007
Study Completion Date: December 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: combination chemotherapy
Simultaneous use of Vinorelbine and Capecitabine
Drug: Vinorelbine and Capecitabine
Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w
Experimental: sequential chemotherapy
Sequential use of Vinorelbine and Capecitabine
Drug: Vinorelbine and Capecitabine
Vinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w

Detailed Description:

The administration of vinorelbine and capecitabine had been implied to be quite useful in metastatic breast cancer. This study was designed to explore whether sequential and simultaneous use of vinorelbine and capecitabine have similar efficacy and whether the sequential way has better tolerability.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent.
  • Female, ≥ 18 and ≤ 70 years.
  • Histologically confirmed invasive breast cancer.
  • Metastatic breast cancer.
  • ECOG Performance Status of 0 to 2.
  • Life expectancy of more than 3 months.
  • Subject must have adequate organ function.
  • Normal laboratory values: hemoglobin > 90g/dl, neutrophils > 1.5×10^9/L, platelets > 80×10^9/L, serum creatinine < 1.5×upper limit of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN.
  • Negative serum pregnancy test for women with childbearing potential.
  • Good conditions for infusion and willing to have phlebotomy throughout whole study.
  • Have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy for more than 28 days.
  • Have at least one target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Exclusion Criteria:

  • Pregnant or lactating females
  • History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible
  • Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
  • Active or uncontrolled infection
  • Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
  • Concomitant with brain metastases
  • Have received chemotherapy after metastasis
  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: NCT00629148

Locations
China
Fudan University Cancer Hospital
Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: XiChun Hu, MD, PhD Fudan University
  More Information

No publications provided

Responsible Party: Xichun Hu/Dr., Fudan University Cancer Hospital
ClinicalTrials.gov Identifier: NCT00629148     History of Changes
Other Study ID Numbers: 2007SSVC
Study First Received: February 26, 2008
Last Updated: July 6, 2011
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
metastasis
chemotherapy
breast cancer
Vinorelbine
Capecitabine
sequential chemotherapy
TTF

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Vinorelbine
Vinblastine
Capecitabine
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014