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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

September 4, 2007
September 13, 2010
November 2006
August 2008   (final data collection date for primary outcome measure)
Circulating VEGF levels in breast cancer patients with bone metastases [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Circulating VEGF levels in breast cancer patients with bone metastases [ Time Frame: one month ]
Complete list of historical versions of study NCT00524849 on ClinicalTrials.gov Archive Site
  • 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 ]
Time to first skeletal-related event; Time to bone progression disease; Progression-free survival; Overall survival [ Time Frame: 3 years ]
Not Provided
Not Provided
 
Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis
Randomized Phase 2 Study on the Relationship Between Circulating VEGF and Weekly or Every-four-week Zometa in Breast Cancer Patients With Bone Metastases

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Breast Cancer
  • Bone Metastases
  • Biological: Zoledronic acid
    Zometa 1 mg weekly (intravenous)
    Other Name: Zometa
  • Drug: Zoledronic acid
    Zometa 4 mg every four weeks (intravenous)
  • Active Comparator: conventional Zometa
    Zometa 4mg IV q4w, in combination with other antitumor agents one month after the initial dosing.
    Intervention: Drug: Zoledronic acid
  • Experimental: weekly Zometa
    Weekly Zometa in combination with other antitumor agents one month after the initial dosing.
    Intervention: Biological: Zoledronic acid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2010
August 2008   (final data collection date for primary outcome measure)

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.
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00524849
CZOL446ECN05
No
Xichun Hu/Dr., Fudan University Cancer Hospital
Fudan University
Novartis
Principal Investigator: Xichun Hu, MD, PhD Fudan University
Fudan University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP