Clinical trial · Interventional
Carboplatin, Capecitabine, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck, including 1 of the following types: * Oral cavity * Oropharynx * Hypopharynx * Clinical stage III-IVB (T2-T4, N0-N3, M0) disease * Measurable disease by physical exam, endoscopy, and/or CT scan or MRI * Residual measurable disease after fine needle aspiration, core needle biopsy, or incisional or excisional biopsy of the primary tumor * No evidence of distant metastases (M1) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 9 g/dL * No uncontrolled coagulopathy Hepatic * AST \< 2 times normal * Alkaline phosphatase \< 2 times normal * Bilirubin normal Renal * Creatinine \< 2.0 mg/dL OR * Creatinine clearance \> 50 mL/min Cardiovascular * No congestive heart failure * No symptomatic coronary artery disease * No uncontrolled cardiac arrhythmias * No myocardial infarction within the past year * No other clinically significant cardiac disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 30 days after completion of study treatment * Nutritional and general physical condition must be compatible with proposed study treatment * Mentally reliable * No pre-existing peripheral neuropathy \> grade 1 * No history of hypersensitivity to fluorouracil, capecitabine, or carboplatin * No active infection * No other malignancy within the past 5 years except nonmelanoma skin cancer * No major medical, psychiatric, or neurologic illness that would preclude study participation or giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 5 years since prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for head and neck tumor * No prior radiotherapy to the region of planned study radiotherapy fields Surgery * Recovered from prior surgery * No unhealed surgical wounds Other * More than 4 weeks since prior investigational drugs * No concurrent warfarin, diphenylhydantoin, or fluconazole unless willing to undergo careful monitoring and appropriate dose adjustments
References
Publications (1)
- RESULTThomas CY, Read P, Petroni G, Reibel J, Levine PA. Phase I study of capecitabine, carboplatin and intensity-modulated radiation therapy for head and neck cancer. Anticancer Res. 2009 Jul;29(7):2869-73. PMID 19596976