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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
capecitabine
carboplatin
conventional surgery
radiation therapy
Sponsored by
University of Virginia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia Cancer Center at UV Health System

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 13, 2005
Last Updated
November 25, 2009
Sponsor
University of Virginia
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00114153
Brief Title
Carboplatin, Capecitabine, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Virginia
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Y. Thomas, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul W. Read, MD, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Cancer Center at UV Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19596976
Citation
Thomas 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.
Results Reference
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Carboplatin, Capecitabine, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

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