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Tracking Information | |||||
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First Received Date † | November 16, 2006 | ||||
Last Updated Date | January 29, 2009 | ||||
Start Date † | June 2002 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00401180 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Activity [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Docetaxel and Temozolomide in Treating Patients With Metastatic Cancer | ||||
Official Title † | Phase I Trial of Weekly Docetaxel and Daily Temozolomide in Patients With Metastatic Disease | ||||
Brief Summary | 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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment | ||||
Condition † | Unspecified Adult Solid Tumor, Protocol Specific | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | Tamaskar I, Mekhail T, Dreicer R, Olencki T, Roman S, Elson P, Bukowski RM. Phase I trial of weekly docetaxel and daily temozolomide in patients with metastatic disease. Invest New Drugs. 2008 Dec;26(6):553-9. Epub 2008 Jul 15. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 24 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00401180 | ||||
Responsible Party | |||||
Secondary IDs †† | CASE-CCF-4737 | ||||
Study Sponsor † | Case Comprehensive Cancer Center | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | September 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |