|
Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases Clinical research trials and Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases. Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases clinical trial. Participants oftentimes recieve the most expert healthcare available for their Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "M" Clinical Trials Conditions > Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases  Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
For Condition: bone metastases,stage 4 breast cancer,Hypercalcemia,recurrent breast cancer,Pain
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. It is not yet known whether monoclonal antibody is more effective than zoledronate in treating women who have breast cancer and bone metastases. PURPOSE: Randomizedphase I/II trial to compare the effectiveness of monoclonal antibody with that of zoledronate in treating women who have breast cancer and bone metastases.
Details: OBJECTIVES: - Compare the safety and tolerability of monoclonal antibody CAL vs zoledronate in women with breast cancer and bone metastases. - Compare, preliminarily, the potential effects of these drugs on skeletal events/manifestations related to bone metastases, including hypercalcemia, bone pain, bone metastatic lesions, complications (e.g., pathologic fracture and spinal cord compression), and interventions (e.g., surgery and radiotherapy) in these patients. - Compare changes in ECOG performance status in patients treated with these drugs. - Determine the pharmacokinetics of monoclonal antibody CAL in these patients. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to average prestudy pain score on question 3 of a daily electronic telephone pain diary (less than 3 vs 3 or more) and prior bisphosphonate therapy (yes vs no). Patients are randomized to 1 of 4 treatment arms. - Arm I: Patients receive monoclonal antibody CAL IV over 30-60 minutes on day 1. - Arm II: Patients receive a lower dose of monoclonal antibody CAL as in arm I. - Arm III: Patients receive a lower dose (lower than arm II) of monoclonal antibody CAL as in arm I. - Arm IV: Patients receive zoledronate IV over 30-60 minutes on day 1. Treatment in all arms repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients keep a pain diary throughout study participation. Patients are followed at 24 weeks. PROJECTED ACCRUAL: A total of 72 patients (18 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed breast cancer - Radiographical evidence of at least 1 bone metastasis - No prior radiotherapy or surgery to bone metastasis - No radiotherapy or surgery anticipated for bone metastasis within the next 24 weeks - Bone pain severity score of at least 1 on 5 of 7 days as determined by question 3 of the Brief Pain Inventory (BPI) - No bone metastases to a weight-bearing bone at imminent risk for pathologic fracture or surgical intervention - No vertebral metastases that place the patient at imminent risk of spinal cord compression - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Pre- or post-menopausal Performance status - ECOG 0-2 Life expectancy - At least 6 months Hematopoietic - WBC at least 2,000/mm^3 - Lymphocyte count at least 500/mm^3 - Granulocyte count at least 1,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic - ALT or AST no greater than 2.5 times upper limit of normal (ULN) - Bilirubin no greater than 1.5 times ULN Renal - Calcium no greater than 10.1 mg/dL - No oliguria, defined as less than 30 mL urine per 2-hour collection - No acute renal failure - Creatinine no greater than 2.5 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - No sepsis - No known or anticipated contraindication to study drugs PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 3 weeks since initiation of a new chemotherapy regimen Endocrine therapy - More than 3 weeks since initiation of a new hormonal therapy regimen Radiotherapy - See Disease Characteristics - More than 3 weeks since prior radiotherapy Surgery - See Disease Characteristics Other - More than 60 days since prior bisphosphonates - More than 30 days since prior investigational drugs - No change in analgesic drug regimen during the screening period
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulaSilverman, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Paula Silverman 216-844-8510
Additional Information:
Study ID Numbers: CDR0000299530; CBI-CAL-03,CWRU-080235,CBI-1102
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060138
Other Recurrent Breast Cancer Studies:
1. Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
2. Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
3. Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer
4. Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer
5. Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
|
|
|
|
|
|
|
|
