Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00524849
First received: September 4, 2007
Last updated: September 13, 2010
Last verified: September 2010
  Purpose

The primary objective of this study is to evaluate the effects of Zometa (zoledronic acid, 1 mg per week versus 4 mg every four weeks) on the circulating vascular endothelial growth factor (VEGF) levels in breast cancer patients with bone metastases. Sixty patients will be randomized into two groups.


Condition Intervention Phase
Metastatic Breast Cancer
Bone Metastases
Biological: Zoledronic acid
Drug: Zoledronic acid
Phase 2
Phase 3

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 Phase 2 Study on the Relationship Between Circulating VEGF and Weekly or Every-four-week Zometa in Breast Cancer Patients With Bone Metastases

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Circulating VEGF levels in breast cancer patients with bone metastases [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to first skeletal-related event [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Time to bone progression disease [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: November 2006
Study Completion Date: January 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conventional Zometa
Zometa 4mg IV q4w, in combination with other antitumor agents one month after the initial dosing.
Drug: Zoledronic acid
Zometa 4 mg every four weeks (intravenous)
Experimental: weekly Zometa
Weekly Zometa in combination with other antitumor agents one month after the initial dosing.
Biological: Zoledronic acid
Zometa 1 mg weekly (intravenous)
Other Name: Zometa

Detailed Description:

The administration of Zometa in short intervals has been implied to be more potent in maximizing its antitumor and antiangiogenesis effects, while dosing every four weeks is an appropriate strategy for the prevention and management of bone metastases. This study was designed to explore the relationship between dosing of Zometa and level of circulating VEGF.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Female, 18 years or older
  • Histologically confirmed invasive breast cancer
  • Bone metastases
  • ECOG Performance Status of 0 to 2
  • Life expectancy of more than 3 months
  • Subject must have adequate organ function:

    • Cr ≤ 3 mg/dL (265 µmol/L),
    • CrCl (Cockcroft & Gault) ≥ 30 mL/min,
    • Ca2+ > 8.0 mg/dL (2.0 mmol/L) and ≤ 12 mg/dL (3.0 mmol/L)
  • Negative serum pregnancy test for women with childbearing potential
  • Good conditions for infusion and willing to undergo phlebotomy during the whole study
  • Have ceased anti-tumor treatment including chemotherapy, endocrinotherapy and bio-targeted therapy for over 28 days

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
  • Current active dental problems including infection of the teeth or jawbone (maxilla or mandible); dental or fixture trauma; or a current or prior diagnosis of osteonecrosis of the jaw (ONJ); or exposed bone in the mouth; or slow healing after dental procedures
  • Recent (within 6 weeks of Randomization) or planned dental or jaw surgery (e.g. extraction, implants)
  • Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
  • Concomitant with liver, brain or symptomatic lung metastases (symptoms such as hemoptysis, severe cough and shortness of breath)
  • Accepted radiotherapy for solitary bone disease within 30 days before study
  • Previous treatment with other bisphosphonates or radionuclides within one month before study
  • Known hypersensitivity to bisphosphonates
  • History of treatment with calcitonin, gallium nitrate or mithracin within 14 days before study.
  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: NCT00524849

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xichun Hu/Dr., Fudan University Cancer Hospital
ClinicalTrials.gov Identifier: NCT00524849     History of Changes
Other Study ID Numbers: CZOL446ECN05
Study First Received: September 4, 2007
Last Updated: September 13, 2010
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Breast cancer
Bone metastasis
Circulating VEGF
Zoledronic acid
Angiogenesis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Endothelial Growth Factors
Zoledronic acid
Diphosphonates
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014