NCT00114153

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2005

Completed
Last Updated

November 26, 2009

Status Verified

April 1, 2007

First QC Date

June 13, 2005

Last Update Submit

November 25, 2009

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the oropharynx

Interventions

capecitabineDRUG
carboplatinDRUG
conventional surgeryPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Cancer Center at UV Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • 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.

    PMID: 19596976RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

CapecitabineCarboplatinRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic ChemicalsTherapeutics

Study Officials

  • Christopher Y. Thomas, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

  • Paul W. Read, MD, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2005

First Posted

June 14, 2005

Study Start

June 1, 2003

Last Updated

November 26, 2009

Record last verified: 2007-04

Locations

US(1)