Carboplatin, Capecitabine, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00114153
Recruitment Status : Completed
First Posted : June 14, 2005
Last Update Posted : November 26, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: capecitabine Drug: carboplatin Procedure: conventional surgery Radiation: radiation therapy Phase 1

Detailed Description:



  • 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
Primary Purpose: Treatment
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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 9 g/dL
  • No uncontrolled coagulopathy


  • AST < 2 times normal
  • Alkaline phosphatase < 2 times normal
  • Bilirubin normal


  • Creatinine < 2.0 mg/dL OR
  • Creatinine clearance > 50 mL/min


  • 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


  • 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


Biologic therapy

  • Not specified


  • More than 5 years since prior chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy for head and neck tumor
  • No prior radiotherapy to the region of planned study radiotherapy fields


  • Recovered from prior surgery

    • No unhealed surgical wounds


  • More than 4 weeks since prior investigational drugs
  • No concurrent warfarin, diphenylhydantoin, or fluconazole unless willing to undergo careful monitoring and appropriate dose adjustments

Information from the National Library of Medicine

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 identifier (NCT number): NCT00114153

United States, Virginia
University of Virginia Cancer Center at UV Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
National Cancer Institute (NCI)
Principal Investigator: Christopher Y. Thomas, MD University of Virginia
Principal Investigator: Paul W. Read, MD, PhD University of Virginia

Publications of Results: Identifier: NCT00114153     History of Changes
Other Study ID Numbers: CDR0000432949
First Posted: June 14, 2005    Key Record Dates
Last Update Posted: November 26, 2009
Last Verified: April 2007

Keywords provided by National Cancer Institute (NCI):
stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the oropharynx

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action