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| Sponsored by: |
Novartis Pharmaceuticals |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003884 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercalcemia Lung Cancer Metastatic Cancer Pain Unspecified Adult Solid Tumor, Protocol Specific |
Drug: zoledronic acid Procedure: quality-of-life assessment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized |
| 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 |
| Estimated Enrollment: | 600 |
| Study Start Date: | August 1998 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Show 55 Study Locations| Study Chair: | Robert Knight, MD | Novartis Pharmaceuticals |
More Information
| Study ID Numbers: | CDR0000067052, NOVARTIS-4244603011 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003884 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent non-small cell lung cancer recurrent small cell lung cancer unspecified adult solid tumor, protocol specific |
bone metastases hypercalcemia pain |
|
Thoracic Neoplasms Zoledronic acid Metabolic Diseases Adjuvants, Immunologic Hypercalcemia Breast Neoplasms Bone Density Conservation Agents Pain Recurrence Multiple Myeloma Carcinoma, Small Cell |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis Non-small Cell Lung Cancer Water-Electrolyte Imbalance Metabolic Disorder Prostatic Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasms, Plasma Cell |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Zoledronic acid Metabolic Diseases Physiological Effects of Drugs Hypercalcemia Bone Density Conservation Agents Pharmacologic Actions Calcium Metabolism Disorders |
Neoplasms Neoplastic Processes Pathologic Processes Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis Water-Electrolyte Imbalance |
