Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone

Phase 3

Completed

• Conditions: Hypercalcemia of Malignancy; Lung Cancer; Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00003884
• Lead Sponsor: Novartis

Brief Summary

RATIONALE: Zoledronate may help to relieve some of the symptoms caused by bone metastases. It is not yet known if zoledronate is more effective than no further therapy in relieving symptoms of bone metastases or preventing disease progression.

PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in treating patients who have solid tumors that have spread to the bone.

Detailed Description

OBJECTIVES: I. Assess the safety and efficacy of zoledronate in patients with any solid tumor cancer with bone metastases other than breast or prostate cancer. II. Assess the efficacy of zoledronate in preventing skeletal-related events including tumor induced hypercalcemia (TIH), time to first occurrence of skeletal-related event or TIH, skeletal morbidity rate, time to progression of bone metastases, overall survival, and time to overall disease progression in these patients. III. Assess the quality of life and pain in these patients on these regimens.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified into two groups: patients with lung cancer and patients with all other solid tumor cancers. Patients are randomly assigned to receive 1 of the following treatments: Arm I: Patients receive intravenous zoledronate over 5 minutes every 3 weeks for 9 months. Arm II: Patients receive intravenous zoledronate at a higher dose over 5 minutes every 3 weeks for 9 months. Arm III: Patients receive intravenous placebo over 5 minutes every 3 weeks for 9 months. All patients receive oral calcium daily, and an oral multivitamin supplement. Quality of life is assessed prior to therapy, then at months 3, 6, and 9. Patients are followed every 6 months for survival.

PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study within 12 months.

Study Timeline

• Study Start: 1998-08
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-01
• Study Completion: 2001-01
• Study First Submitted QC: 2004-07-21
• Study First Posted: 2004-07-22
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (55)

SORRA Research Center; 🇺🇸 Birmingham, Alabama, United States

Brookwood ACCC; 🇺🇸 Birmingham, Alabama, United States

University of Alabama Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Highlands Oncology Group; 🇺🇸 Springdale, Arkansas, United States

Columbia South Valley Hospital; 🇺🇸 Gilroy, California, United States

Pacific Shores Medical Group; 🇺🇸 Long Beach, California, United States

Veterans Affairs Medical Center - West Los Angeles; 🇺🇸 Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States

Southwest Cancer Care; 🇺🇸 Poway, California, United States

Cancer and Blood Institute of the Desert; 🇺🇸 Rancho Mirage, California, United States

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