Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases
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|ClinicalTrials.gov Identifier: NCT00026494|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 18, 2016
Last Update Posted : January 18, 2016
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of temozolomide and vinorelbine in treating patients who have recurrent brain metastases.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Drug: temozolomide Drug: vinorelbine tartrate||Phase 1 Phase 2|
- Determine the maximum tolerated dose of vinorelbine when administered in combination with temozolomide in patients with recurrent brain metastases (phase I accrual completed).
- Determine the safety and feasibility of this treatment regimen in these patients.
- Determine the efficacy of this treatment regimen, in terms of objective radiographic response and overall and progression-free survival, in these patients.
OUTLINE: This is a dose-escalation study of vinorelbine.
Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and oral temozolomide once daily on days 1-7 and 15-21. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-35 patients will be treated at that dose level.
Patients are followed every 3-4 months.
PROJECTED ACCRUAL: A minimum of 3 patients will be accrued for the phase I portion of this study and 20-35 patients will be accrued for the phase II portion of this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial Of Temozolomide And Vinorelbine For Patients With Recurrent Brain Metastases|
|Study Start Date :||July 2001|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
Experimental: Temozolomide and Vinorelbine
Patients will be treated with vinorelbine on days 1 and 8 of each cycle; temozolomide will be administered on days 1 to 7 and 15 to 21 of each cycle. The dose level of temozolomide will be given at a dose of 150 mg/m2/day. A cycle will be defined as 28 days of treatment.
|Drug: temozolomide Drug: vinorelbine tartrate|
- Radiographic Response Assessed by Macdonald Criteria Every 2 Months [ Time Frame: 2 years ]All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026494
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Lauren E. Abrey, MD||Memorial Sloan Kettering Cancer Center|