Carboplatin, Capecitabine, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00114153|
Recruitment Status : Completed
First Posted : June 14, 2005
Last Update Posted : November 26, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: capecitabine Drug: carboplatin Procedure: conventional surgery Radiation: radiation therapy||Phase 1|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|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|
|Study Start Date :||June 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114153
|United States, Virginia|
|University of Virginia Cancer Center at UV Health System|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Christopher Y. Thomas, MD||University of Virginia|
|Principal Investigator:||Paul W. Read, MD, PhD||University of Virginia|