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Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer

This study is currently recruiting participants.
Verified January 2012 by Harbin Medical University
Sponsor:
Information provided by (Responsible Party):
Qingyuan Zhang, Harbin Medical University
ClinicalTrials.gov Identifier:
NCT01483300
First received: November 25, 2011
Last updated: January 22, 2012
Last verified: January 2012
History of Changes
  Purpose

Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line treatment for metastatic breast cancer patients, especially for those previously treated with anthracyclines and taxanes. Lobaplatin, as the third generation of new cancer drug platinum, has a similar anticancer activity to cisplatin, but less kidney toxicity and gastrointestinal reaction. The purpose of the study is to compare the efficacy and safety of gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
 Drug: lobaplatin
Drug: cisplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Harbin Medical University:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 4 weeks after chemotherapy ] [ Designated as safety issue: No ]
    Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)


Secondary Outcome Measures:
  • Time to progression [ Time Frame: one year after last patient in ] [ Designated as safety issue: No ]
    Time to progression defined as time from randomization to disease progress.

  • Overall Survival [ Time Frame: one year after last patient in ] [ Designated as safety issue: No ]
    Overall survival defined as time from randomization to death from any cause.

  • Treatment related toxicity [ Time Frame: 4 weeks after chemotherapy ] [ Designated as safety issue: Yes ]
    Treatment related toxicities will be recorded as chemotherapy toxicity grades in hematologic, renal, hepatic and gastrointestinal system.


Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lobaplatin
gemcitabine plus lobaplatin
 Drug: lobaplatin
Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks
Active Comparator: cisplatin
gemcitabine plus cisplatin
 Drug: cisplatin
Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed metastatic breast cancer
  • Disease progression during or after previous 1st line chemotherapy
  • Scheduled to receive 2nd line chemotherapy.
  • Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension
  • 18 years of age or older
  • ECOG performance status of 0-2
  • Life expectancy of greater than 6 months

Exclusion Criteria:

  • Previous treatment with one of the study drugs
  • Application of other cytotoxic chemotherapy or radiotherapy
  • Insufficent renal function (creatinine clearance < 60ml/min)
  • Clinically unstable brain metastasis
  • Pregancy or lactation
  • History of other malignancy within last 5 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483300

Contacts
Contact: Qingyuan Zhang, MD 86-451-86298276 zhma19650210@163.com
Contact: Xinmei Kang, MD 86-451-86298683 kxm791107@163.com

Locations
China, Heilongjiang
Cancer Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150081
Contact: Qingyuan Zhang, MD     86-451-86298276     zhma19650210@163.com    
Contact: Xinmei Kang, MD     86-451-86298683     kxm791107@163.com    
Principal Investigator: Qingyuan Zhang, MD            
Sub-Investigator: Xinmei Kang, MD            
Sponsors and Collaborators
Harbin Medical University
Investigators
Study Director: Qingyuan Zhang, MD Cancer Hospital of Harbin Medical University
Principal Investigator: Xinmei Kang, MD Cancer Hospital of Harbin Medical University
  More Information

No publications provided

Responsible Party: Qingyuan Zhang, Vice president of Cancer Hospital of Harbin Medical University, Harbin Medical University
ClinicalTrials.gov Identifier: NCT01483300     History of Changes
Other Study ID Numbers: BC001
Study First Received: November 25, 2011
Last Updated: January 22, 2012
Health Authority: China: Ethics Committee

Keywords provided by Harbin Medical University:
breast cancer
gemcitabine
lobaplatin
cisplatin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013