Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114153
Status:
COMPLETED
Last Update Posted:
2009-11-26
First Post:
2005-06-13
Brief Title:
Carboplatin Capecitabine and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Sponsor:
University of Virginia
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of Induction Paraplatin and Xeloda Followed by Concurrent Paraplatin and Xeloda With Intensity Modulated Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2007-04
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 Drugs used in chemotherapy such as carboplatin and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving chemotherapy together with radiation therapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of capecitabine when given together with carboplatin followed by radiation therapy in treating patients with stage III or stage IV head and neck cancer
PURPOSE This phase I trial is studying the side effects and best dose of capecitabine when given together with carboplatin followed by radiation therapy in treating patients with stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose MTD of capecitabine when administered with carboplatin as induction chemotherapy in patients with stage III-IVB squamous cell carcinoma of the head and neck
Determine the MTD of capecitabine when administered with concurrent carboplatin and intensity-modulated radiotherapy in these patients
Determine the toxicity of this regimen in these patients
Secondary
Determine preliminarily tumor response in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
OUTLINE This is a dose-escalation study of capecitabine
Induction chemotherapy Patients receive carboplatin IV on days 1 8 15 22 29 and 36 and oral capecitabine twice daily on days 1-14 and 22-35
Concurrent chemoradiotherapy Beginning 2 weeks after completion of induction chemotherapy patients receive carboplatin and capecitabine as in induction chemotherapy Patients also undergo intensity-modulated radiotherapy IMRT once daily on days 1-5 8-12 15-19 22-26 and 29-33 and non-IMRT boost once daily on days 36-40 and 43-47
Treatment continues in the absence of disease progression or unacceptable toxicity
Within 4-8 weeks after completion of concurrent chemoradiotherapy patients who achieve a clinical complete response or who are medically operable with resectable persistent or recurrent disease undergo neck dissection salvage surgery
Cohorts of 3-6 patients receive escalating doses of capecitabine during both induction chemotherapy and concurrent chemoradiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Quality of life is assessed at baseline after completion of induction chemotherapy and then at 1 week and 3 6 and 12 months after completion of concurrent chemoradiotherapy
After completion of study therapy patients are followed monthly for 3 months and then every 3 months for 1 year
PROJECTED ACCRUAL Approximately 6-48 patients will be accrued for this study
Primary
Determine the maximum tolerated dose MTD of capecitabine when administered with carboplatin as induction chemotherapy in patients with stage III-IVB squamous cell carcinoma of the head and neck
Determine the MTD of capecitabine when administered with concurrent carboplatin and intensity-modulated radiotherapy in these patients
Determine the toxicity of this regimen in these patients
Secondary
Determine preliminarily tumor response in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
OUTLINE This is a dose-escalation study of capecitabine
Induction chemotherapy Patients receive carboplatin IV on days 1 8 15 22 29 and 36 and oral capecitabine twice daily on days 1-14 and 22-35
Concurrent chemoradiotherapy Beginning 2 weeks after completion of induction chemotherapy patients receive carboplatin and capecitabine as in induction chemotherapy Patients also undergo intensity-modulated radiotherapy IMRT once daily on days 1-5 8-12 15-19 22-26 and 29-33 and non-IMRT boost once daily on days 36-40 and 43-47
Treatment continues in the absence of disease progression or unacceptable toxicity
Within 4-8 weeks after completion of concurrent chemoradiotherapy patients who achieve a clinical complete response or who are medically operable with resectable persistent or recurrent disease undergo neck dissection salvage surgery
Cohorts of 3-6 patients receive escalating doses of capecitabine during both induction chemotherapy and concurrent chemoradiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Quality of life is assessed at baseline after completion of induction chemotherapy and then at 1 week and 3 6 and 12 months after completion of concurrent chemoradiotherapy
After completion of study therapy patients are followed monthly for 3 months and then every 3 months for 1 year
PROJECTED ACCRUAL Approximately 6-48 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BMS-UVACC-HIC-10519 | None | None | None |
| UVACC-HIC-10519 | None | None | None |
| UVACC-27402 | None | None | None |