NCT00258310

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine after surgery, radiation therapy, and/or chemotherapy may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who have undergone previous surgery, radiation therapy, and/or chemotherapy for head and neck cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_2 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

December 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
4 years until next milestone

Results Posted

Study results publicly available

January 19, 2015

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

7.2 years

First QC Date

November 22, 2005

Results QC Date

November 20, 2014

Last Update Submit

March 7, 2023

Conditions

Head and Neck Cancer

Keywords

stage I squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the larynxstage I squamous cell carcinoma of the lip and oral cavitystage I squamous cell carcinoma of the nasopharynxstage I squamous cell carcinoma of the oropharynxstage II squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the larynxstage II squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the nasopharynxstage II squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the nasopharynxstage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (1)

  • Compliance With Treatment .

    Compliance is defined as taking at least 80% of the prescribed dose for one year.

    within 365 days

Secondary Outcomes (3)

  • Recurrence-free Survival

    Within 3 years of end of study.

  • Overall Survival

    Within 3 years of end of study

  • Incidence of Second Primary Tumors

    Within 3 years of end of study

Study Arms (1)

Capecitabine

EXPERIMENTAL

Surgery, chemotherapy and/or radiotherapy, prior to administration of Capecitabine 1000mg/day for one year.

Drug: capecitabineProcedure: Surgery, chemotherapy and/or radiotherapy

Interventions

capecitabineDRUG

Capecitabine 1000mg/day for one year

Also known as: Xeloda
Capecitabine
Surgery, chemotherapy and/or radiotherapyPROCEDURE

Surgery, chemotherapy and/or radiotherapy

Capecitabine

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 primary tumor sites: * Oral cavity * Oropharynx * Nasopharynx * Hypopharynx * Larynx * Unknown primary * Any disease stage allowed * No evidence of active disease * Must have undergone curative surgical resection, radiotherapy, and/or chemotherapy at least 1 month, but no more than 4 years ago PATIENT CHARACTERISTICS: Performance status * Karnofsky 70-100% Life expectancy * More than 3 months Hematopoietic * White blood count (WBC) ≥ 3,000/mm\^3 * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Hepatitis B and/or C negative Renal * Creatinine clearance \> 50 mL/min Cardiovascular * No myocardial infarction within the past 12 months * No uncontrolled congestive heart failure * No unstable or uncontrolled angina Gastrointestinal * No lack of physical integrity of the upper gastrointestinal tract * Must be able to swallow tablet * No malabsorption syndrome Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer for which the patient is currently in complete remission * No history of uncontrolled seizures, central nervous system (CNS) disorders, or psychiatric disability that would preclude study compliance or giving informed consent * No ongoing postoperative fistula * No prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil * No other serious uncontrolled medical or surgical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Chemotherapy * See Disease Characteristics * Prior oral fluoropyrimidine therapy allowed provided it was given in the adjuvant setting and completed ≥ 12 months ago Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics * More than 4 weeks since prior major surgery and recovered * No prior organ allografts Other * More than 4 weeks since prior participation in any investigational drug study

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

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

CapecitabineSurgical Procedures, Operative

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 Nucleosides

Limitations and Caveats

There were no significant limitations.

Results Point of Contact

Title
George Yoo, M.D.
Organization
Barbara Ann Karmanos Institute
yoog@karmanos.org
(313) 576-9782

Study Officials

  • George H. Yoo, MD

    Barbara Ann Karmanos Cancer Institute

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2005

First Posted

November 24, 2005

Study Start

December 1, 2003

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 10, 2023

Results First Posted

January 19, 2015

Record last verified: 2023-03

Locations

US(1)