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Sponsored by: |
Case Comprehensive Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00401180 |
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 | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: docetaxel Drug: temozolomide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of Weekly Docetaxel and Daily Temozolomide in Patients With Metastatic Disease |
Estimated Enrollment: | 24 |
Study Start Date: | June 2002 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable (by CT scan) or evaluable disease
Prior brain metastasis allowed provided it was definitely treated with external-beam radiotherapy, gamma knife, or surgical resection and is clinically stable
PATIENT CHARACTERISTICS:
No decompensated cardiac arrhythmia or other severe cardiovascular disease (i.e., New York Heart Association [NYHA] class III-IV heart disease)
PRIOR CONCURRENT THERAPY:
No more than 3 courses of prior immunotherapy and/or chemotherapy for metastatic disease
Interferon alfa in the adjuvant setting is not considered a course of prior therapy
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Ronald M. Bukowski, MD | The Cleveland Clinic |
Study ID Numbers: | CDR0000446091, CASE-CCF-4737 |
Study First Received: | November 16, 2006 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00401180 |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Docetaxel Neoplasm Metastasis Temozolomide |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |