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

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed diagnosis of any cancer
other than breast cancer, multiple myeloma, or prostate cancer Objective evidence of bone
metastases discovered within 6 weeks of study entry (patients who at screening present
with an ECOG score of 2) No study entry restrictions for bone metastases for patients with
an ECOG of 0 and 1 No symptomatic brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.5 mg/dL
for liver metastases Renal: Creatinine no greater than 3.0 mg/dL Calcium at least 8.0
mg/dL but less than 12.0 mg/dL Cardiovascular: No history of severe cardiovascular disease
within past 6 months (e.g., congestive heart failure) No hypertension refractory to
treatment No symptomatic coronary artery disease Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception No history of
noncompliance to medical regimen

PRIOR CONCURRENT THERAPY: Biologic therapy: Concurrent biologic response modifier
therapies allowed Concurrent marketed cytokine or colony stimulating factor therapies
allowed Chemotherapy: Concurrent marketed chemotherapy agents allowed (including open
label cooperative trials or for supportive care) Endocrine therapy: Concurrent hormonal
agents and steroid therapies allowed Concurrent corticosteroid therapy allowed (for
chemotherapy induced nausea/vomiting or spinal compression) Radiotherapy: Concurrent
radiotherapy to treat extraskeletal and/or skeletal tumor sites allowed Surgery: Prior
surgery to treat or prevent pathological fracture or spinal cord compression allowed
Other: At least 30 days since other prior investigational drugs No concurrent
bisphosphonate agent At least 30 days since prior bisphosphonate agent (single exposure
allowed within prior 12 months)