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| Sponsors and Collaborators: |
Sylvester Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00077051 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosensitizing drugs, such as cytochlor and tetrahydrouridine, may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining radiosensitizers with chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of cytochlor when given together with tetrahydrouridine, cisplatin and radiation therapy in treating patients with advanced squamous cell carcinoma of the oral cavity (mouth) or oropharynx (throat).
| Condition | Intervention | Phase |
|
Head and Neck Cancer |
Drug: cisplatin Drug: cytochlor Drug: tetrahydrouridine Procedure: radiation therapy |
Phase I |
| MedlinePlus related topics: | Cancer Head and Neck Cancer |
| Drug Information available for: | Cisplatin Deoxycytidine Tetrahydrouridine |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Translational Phase I Trial of Escalating Doses of 5-Chloro-2'-Deoxycytidine (CldC) With a Fixed Dose of Tetrahydrouridine Combined With a Fixed Dose of Cisplatin Comcomitant With Definitive Radiation in Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity and Oropharynx |
| Study Start Date: | April 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study of cytochlor.
Patients receive tetrahydrouridine IV over 5 minutes followed by cytochlor IV for 3 days on week 1 and 5 days a week on weeks 2-4 and cisplatin IV over 30-60 minutes once in weeks 2 and 5. Patients also undergo radiotherapy 5 days a week during weeks 2-7. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of cytochlor until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 3 or 3 of 6 patients experience dose-limiting toxicity.
Patients are followed at 1 month, monthly for 3 months, every 3 months for up to 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 2 years.
Eligibility
| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity or oropharynx
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Florida | |||||
| University of Miami Sylvester Comprehensive Cancer Center | |||||
| Miami, Florida, United States, 33136 | |||||
| Sylvester Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Luis E. Raez, MD, FACP | Sylvester Cancer Center |
| Investigator: | May Abdel-Wahab, MD, PhD | Sylvester Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000352184, SCCC-2002033, NCI-6301 |
| First Received: | February 10, 2004 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00077051 |
| Health Authority: | United States: Federal Government |
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