A Phase 1 interventional study of capecitabine and carboplatin in Head and Neck Cancer, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-11-26.
Sponsored by University of Virginia · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of capecitabine.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's planned enrollment of 48 is close to the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck, including 1 of the following types:
Measurable disease by physical exam, endoscopy, and/or CT scan or MRI
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Recovered from prior surgery
Other
This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.
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University of Virginia