Phase II Trial of Chemotherapy With Temodar With Topotecan for CNS Metastasis of Solid Tumors
The specific purpose of this study is to obtain data on safety and efficacy of combination chemotherapy with Temozolomide and Topotecan in patients with CNS metastases of solid tumors. Up to 35 patients will be accrued over 2-3 years and followed for up to 5 years and will receive 8 cycles of chemotherapy. The primary endpoint is the determinant median overall survival and progression-free survival of this regimen, time to progression of the brain metastases, and assessment of toxicity levels in this regimen.
Central Nervous System (CNS) Metastases
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Chemotherapy With Temozolomide in Combination With Topotecan for Central Nervous System (CNS) Metastasis of Solid Tumors|
- Radiologic Response [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]The primary objective of this study is to determine the overall rate of radiologic response of brain metastases to combination chemotherapy with temozolomide and topotecan in patients with CNS metastases of solid tumors
- Median Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Secondary objectives are to determine median overall survival and progression-free survival on this regimen, to determine time to progression of the brain metastases, and to assess toxicity of this regimen
|Study Start Date:||March 2007|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Temozolomide pills are to be taken on an empty stomach at night and should not be chewed. Patients receive Temozolomide on days 1-5 of a 28-day schedule. Patients will receive Topotecan intravenous treatment days 2-6 of each 28-day cycle at The Mehthodist Hospital Outpatient Infusion Center.
Patients will receive Topotecan intravenous treatment days 2-6 of each 28-day cycle at The Mehthodist Hospital Outpatient Infusion Center.
Other Name: HycamtinDrug: Temozolomide
Temozolomide is taken on an empty stomach at night and should not be chewed. Patients receive Temozolomide on days 1-5 of a 28-day schedule.
Other Name: Temodar
The long-term objective of this research project is to develop chemotherapy-based approach to the treatment of brain metastases. The specific purpose of this study is to obtain data on safety and efficacy of combination chemotherapy with temozolomide and topotecan in patients with central nervous system (CNS) metastases of solid tumors. Patients with brain metastases of solid tumors have a poor prognosis, despite improvements in survival achieved with modern neurosurgical and radiation techniques. Chemotherapy does not play any significant role in this disease, but may have application in salvage of patients who have failed radiation therapy. In patients who are not surgical candidates, do not require immediate XRT to relieve symptoms and have controlled systemic disease, effective chemotherapy as an alternative to XRT might decrease the risk of radiation induced neurotoxicity.
Recent advances in treatment of systemic disease with the use of modern chemotherapy and pathobiologic agents have significantly improved overall survival of cancer patients, putting them at risk for CNS metastases and radiation induced neurotoxicity. Both, temozolomide and topotecan have good blood-brain barrier penetration and have shown activity in CNS malignancies. Preclinical studies suggest synergy of this drug combination. This is a single-arm, open-label phase II drug study. All patients will receive the chemotherapy combination. Up to 35 patients will be accrued over 2-3 years and followed for up to 5 years. Patients will receive up to 8 cycles of chemotherapy. The primary endpoint is the rate of radiologic response of brain metastases and secondary endpoints are median overall survival, progression-free survival, time to progression of brain metastases and toxicity. The study is expected to provide data to be used in generating further research hypotheses.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736800
|United States, Texas|
|Methodist Neurological Institute - Department of Neurosurgery||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Kimbra S Harris, CCRP 713-441-3834 email@example.com|
|Contact: Pamela Z New, M.D. 713-441-3800 firstname.lastname@example.org|
|Principal Investigator: Pamela Z New, M.D.|
|Principal Investigator:||Pamela Z New, M.D.||Methodist Neurological Institute|