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

NCT00524849 | Completed Phase 2

• 1 other identifier: CZOL446ECN05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Breast Cancer; Bone Metastases

Keywords

Breast cancer; Bone metastasis; Circulating VEGF; Zoledronic acid; Angiogenesis

Outcome Measures

Primary Outcomes (1)

• Circulating VEGF levels in breast cancer patients with bone metastases

  one month

Secondary Outcomes (4)

• Time to first skeletal-related event

  3 years

• Time to bone progression disease

  3 years

• Progression-free survival

  3 years

• Overall survival

  3 years

Study Arms (2)

conventional Zometa

ACTIVE COMPARATOR

Zometa 4mg IV q4w, in combination with other antitumor agents one month after the initial dosing.

Drug: Zoledronic acid

weekly Zometa

EXPERIMENTAL

Weekly Zometa in combination with other antitumor agents one month after the initial dosing.

Biological: Zoledronic acid

Interventions

Zoledronic acid BIOLOGICAL

Zometa 1 mg weekly (intravenous)

Also known as: Zometa

weekly Zometa

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• Novartis: collaborator

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (3)

• Santini D, Vincenzi B, Dicuonzo G, Avvisati G, Massacesi C, Battistoni F, Gavasci M, Rocci L, Tirindelli MC, Altomare V, Tocchini M, Bonsignori M, Tonini G. Zoledronic acid induces significant and long-lasting modifications of circulating angiogenic factors in cancer patients. Clin Cancer Res. 2003 Aug 1;9(8):2893-7.

  PMID: 12912933 BACKGROUND

• Zhao X, Xu X, Zhang Q, Jia Z, Sun S, Zhang J, Wang B, Wang Z, Hu X. Prognostic and predictive value of clinical and biochemical factors in breast cancer patients with bone metastases receiving "metronomic" zoledronic acid. BMC Cancer. 2011 Sep 22;11:403. doi: 10.1186/1471-2407-11-403.

  PMID: 21936956 DERIVED

• Zhao X, Xu X, Guo L, Ragaz J, Guo H, Wu J, Shao Z, Zhu J, Guo X, Chen J, Zhu B, Wang Z, Hu X. Biomarker alterations with metronomic use of low-dose zoledronic acid for breast cancer patients with bone metastases and potential clinical significance. Breast Cancer Res Treat. 2010 Dec;124(3):733-43. doi: 10.1007/s10549-010-1183-6. Epub 2010 Sep 30.

  PMID: 20882405 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xichun Hu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 5, 2007
• Study Start: November 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: January 1, 2010
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

CN (1)