Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077051
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2004-02-10
Brief Title:
Cytochlor and Tetrahydrouridine as Radiosensitizers and Cisplatin Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity Mouth or Oropharynx Throat
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
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 Concomitant With Definitive Radiation in Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity and Oropharynx
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Primary
Determine the dose range of cytochlor to be used in phase II trials based on safety toxicity and tissue selectivity in patients with advanced squamous cell carcinoma of the oral cavity or oropharynx
Determine the safety and toxicity profile of cytochlor tetrahydrouridine and concurrent radiotherapy followed by radiotherapy alone in these patients
Determine the percentage of cancer cells vs normal cells that incorporate cytochlor in the DNA of patients treated with this regimen
Determine the percentage replacement of thymine by 5-chlorouracil in tumors vs normal tissue of patients treated with this regimen
Secondary
Determine the tissue selectivity of this regimen in these patients
Determine the level of cytochlor and its metabolites within the serum and urine of these patients during combination treatment and before radiotherapy alone is initiated
Determine the pharmacokinetics of this regimen in these patients
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
Primary
Determine the dose range of cytochlor to be used in phase II trials based on safety toxicity and tissue selectivity in patients with advanced squamous cell carcinoma of the oral cavity or oropharynx
Determine the safety and toxicity profile of cytochlor tetrahydrouridine and concurrent radiotherapy followed by radiotherapy alone in these patients
Determine the percentage of cancer cells vs normal cells that incorporate cytochlor in the DNA of patients treated with this regimen
Determine the percentage replacement of thymine by 5-chlorouracil in tumors vs normal tissue of patients treated with this regimen
Secondary
Determine the tissue selectivity of this regimen in these patients
Determine the level of cytochlor and its metabolites within the serum and urine of these patients during combination treatment and before radiotherapy alone is initiated
Determine the pharmacokinetics of this regimen in these patients
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-6301 | None | None | None |
| SCCC-2002033 | None | None | None |