Pain Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Zoledronate (4 and 8 mg) Administered Intravenously as an Adjuvant to Anticancer Therapy to Patients With Any Cancer With Bone Metastases Other Than Breast Cancer, Multiple Myeloma or Prostate Cancer
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.
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.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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