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| Sponsor: | Rochester General Hospital |
|---|---|
| Collaborator: |
Novartis Pharmaceuticals |
| Information provided by: | Rochester General Hospital |
| ClinicalTrials.gov Identifier: | NCT01004510 |
Purpose
The purpose of this study is to evaluate whether the addition of the bisphosphonate Zometa (zoledronic acid) used along with standard regimens of chemotherapy, will help to control the need for palliative intervention of malignant pleural effusions due to non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Pleural Effusion Non Small Cell Lung Cancer |
Drug: zoledronic acid |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | An Open-Label Phase II Study of Zometa as Adjuvant Treatment of Malignant Pleural Effusion Due to Non-Small Cell Lung Cancer |
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Zoledronic Acid: Experimental
Monthly zoledronic acid in addition to chemotherapy
|
Drug: zoledronic acid
Zoledronic acid (Zometa) 4mg IV every 4 weeks for 3 treatments with chemotherapy as selected by treating physician
|
Malignant pleural effusions are common in late stage non-small cell lung cancer and can lead to significantly increased morbidity in this patient population. The majority of patients are symptomatic due to their malignant effusions. The recurrence rates are thought to be quite high overall and may approach 100% without any further treatment.Currently there is no available non-invasive, medical means for controlling the effusions other than systemic chemotherapy.Zoledronic acid has been shown in a mouse model of malignant pleural effusion to decrease fluid accumulation and tumor dissemination while prolonging survival.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Todd Sheppard, M.D. | 585-922-4409 | todd.sheppard@rochestergeneral.org |
| Contact: Peter Bushunow, M.D. | 585-922-4020 | peter.bushunow@rochestergeneral.org |
| United States, New York | |
| Rochester General Hospital | |
| Rochester, New York, United States, 14621 | |
| Principal Investigator: | Todd Sheppard, M.D. | Rochester General Hospital |
| Principal Investigator: | Peter Bushunow, M.D. | Rochester General Hospital |
| Principal Investigator: | Kevin Lightner, M.D. | Rochester General Hospital |
More Information
| Responsible Party: | Rochester General Hospital ( Todd Sheppard M.D./Principal Investigator ) |
| Study ID Numbers: | US CZOL446EUS143T |
| Study First Received: | October 29, 2009 |
| Last Updated: | November 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT01004510 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
malignant pleural effusion non small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Zoledronic acid Neoplasms by Histologic Type Pleural Diseases Physiological Effects of Drugs Pleural Effusion, Malignant Bone Density Conservation Agents Pharmacologic Actions Carcinoma |
Pleural Effusion Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Pleural Neoplasms Neoplasms, Glandular and Epithelial |