Docetaxel and Temozolomide in Treating Patients With Metastatic Cancer
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|ClinicalTrials.gov Identifier: NCT00401180|
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : July 8, 2011
RATIONALE: Drugs used in chemotherapy, such as docetaxel and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel and temozolomide in treating patients with metastatic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: docetaxel Drug: temozolomide||Phase 1|
- Determine the toxicity profile, dose-limiting toxicity, and maximum tolerated dose of docetaxel and temozolomide (TMZ) in patients with metastatic cancer.
- Determine the activity of docetaxel and TMZ in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral temozolomide once daily on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of docetaxel and temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 6 patients receive treatment at the MTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Weekly Docetaxel and Daily Temozolomide in Patients With Metastatic Disease|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
- Maximum tolerated dose [ Time Frame: 4 cycles ]
- Dose-limiting toxicity [ Time Frame: 4 cycles ]
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): NCT00401180
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Ronald M. Bukowski, MD||The Cleveland Clinic|