Expired Study
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Los Angeles, California 90095


Purpose:

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Zoledronate may delay or prevent the formation of bone metastases. It is not yet known whether chemotherapy is more effective with or without zoledronate in treating non-small cell lung cancer and preventing bone metastases. PURPOSE: This randomized phase II trial is studying docetaxel and carboplatin alone to see how well it works compared to giving docetaxel and carboplatin together with zoledronate in treating patients with unresectable stage IIIB or stage IV non-small cell lung cancer.


Study summary:

OBJECTIVES: Primary - Compare the proportion of patients without disease progression at 6 months among patients with unresectable stage IIIB or stage IV non-small cell lung cancer treated with docetaxel and carboplatin with vs without zoledronate. Secondary - Compare time to disease progression in patients treated with these regimens. - Compare response rate in patients treated with these regimens. - Compare time to progression in bone in patients treated with these regimens. - Compare 1-year overall survival in patients treated with these regimens. - Compare the safety of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive docetaxel IV over 1 hour followed by zoledronate IV over 15 minutes and carboplatin IV over 15 minutes on day 1. - Arm II: Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 15 minutes on day 1. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of therapy, patients in arm I who have responding or stable disease are then re-randomized to 1 of 2 arms. - Arm I: Patients receive zoledronate IV over 15 minutes monthly for 12 months from the date of the first chemotherapy dose. - Arm II: Patients receive no further treatment. Patients are followed every 1 or 3 months for 12 months from the date of the first chemotherapy dose. PROJECTED ACCRUAL: Approximately 250 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed non-small cell lung cancer (NSCLC), including squamous cell carcinoma, adenocarcinoma, and large cell carcinoma - Unresectable stage IIIB disease, including patients with pleural effusion - Patients with stage IIIB who are candidates for combined chemotherapy and chest irradiation are not eligible - Stage IV disease - No mixed tumors with small cell carcinoma or aplastic carcinoma - Measurable disease - At least one measurable lesion outside a previously irradiated area and detectable by radiologic studies - No bone metastases - No brain metastases unless treated and stable for at least 8 weeks PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 3 months Hematopoietic - WBC ≥ 1,500/mm^3 - Neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9.0 g/dL Hepatic - Bilirubin ≤ upper limit of normal (ULN) - Alkaline phosphatase and AST/ALT must meet criteria for one of the following: - AST or ALT ≤ 5 times ULN AND alkaline phosphatase ≤ ULN - AST or ALT ≤1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN - AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN - No hepatic disease that would preclude prolonged follow-up Renal - Creatinine clearance > 60 mL/min - Calcium ≥ 8.0 mg/dL (corrected) - No renal disease that would preclude prolonged follow-up Cardiovascular - No cardiovascular disease that would preclude prolonged follow-up Pulmonary - No pulmonary disease that would preclude prolonged follow-up Other - No weight loss > 5% within the past 6 months - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except treated melanoma, ductal carcinoma in situ of the cervix, or other cancer cured by resection alone - No known hypersensitivity to zoledronate, other bisphosphonates, platinum-containing compounds, mannitol, or polysorbate 80 - No peripheral neuropathy > grade 1 - No uncontrolled infections - No uncontrolled type 2 diabetes mellitus - No disease with influence on bone metabolism, including any of the following: - Paget's disease - Uncontrolled thyroid dysfunction - Uncontrolled parathyroid dysfunction - No neurologic/psychiatric disease that would preclude prolonged follow-up - No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior first-line chemotherapy - Prior adjuvant or neoadjuvant treatment (including paclitaxel) for NSCLC is allowed Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - No prior radiotherapy covering > 30% of marrow-bearing areas - No concurrent radiotherapy Surgery - More than 3 weeks since prior thoracotomy and recovered Other - More than 30 days since prior systemic investigational drugs or devices - More than 1 year since prior bisphosphonates - No other concurrent bisphosphonates - No other concurrent osteoclastic bone resorption inhibitors (e.g., calcitonin, mithramycin, or gallium nitrate) - No other concurrent investigational drugs or devices - No other concurrent antineoplastic agents during the treatment phase of study


NCT ID:

NCT00093717


Primary Contact:

Study Chair
Robert A. Figlin, MD, FACP
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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