Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004246
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
2000-01-28
Brief Title:
Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth Pharynx or Larynx
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Study of Fludarabine With Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2018-10
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of radiation therapy plus fludarabine in treating patients who have locally advanced cancer of the mouth pharynx or larynx
PURPOSE Phase I trial to study the effectiveness of radiation therapy plus fludarabine in treating patients who have locally advanced cancer of the mouth pharynx or larynx
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of fludarabine that can be given during the sixth and seventh weeks of radiotherapy in patients with locally advanced squamous cell carcinoma of the oral cavity pharynx or larynx based on the systemic toxicity of the drug and the acute mucosal reactions in the irradiated fields II Document the qualitative and quantitative toxicity of this combination therapy in this patient population
OUTLINE This is a dose escalation study of fludarabine Patients receive radiotherapy on days 1-5 for 7 weeks Patients receive fludarabine IV on days 1-5 of weeks 6 and 7 of radiotherapy Fludarabine is administered 3-4 hours prior to daily radiotherapy Cohorts of 3 patients receive escalating doses of fludarabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose that produces a severe toxicity rate nearest to 20 Patients are followed every 4 weeks after the completion of treatment until acute reactions have resolved then every 3 months for 2 years every 4 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A maximum of 18 patients will be accrued for this study within 15 years
OUTLINE This is a dose escalation study of fludarabine Patients receive radiotherapy on days 1-5 for 7 weeks Patients receive fludarabine IV on days 1-5 of weeks 6 and 7 of radiotherapy Fludarabine is administered 3-4 hours prior to daily radiotherapy Cohorts of 3 patients receive escalating doses of fludarabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose that produces a severe toxicity rate nearest to 20 Patients are followed every 4 weeks after the completion of treatment until acute reactions have resolved then every 3 months for 2 years every 4 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A maximum of 18 patients will be accrued for this study within 15 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 |
|---|---|---|---|
| CDR0000067492 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP01CA006294 |
| P30CA016672 | NIH | None | None |
| P01CA006294 | NIH | None | None |
| MDA-ID-95038 | OTHER | None | None |
| NCI-H99-0046 | None | None | None |