A Study of a New Combination and Schedule of Chemotherapy Drugs for the Treatment of Head and Neck Cancer - Full Text View

Sponsor:	University of Michigan Cancer Center
Information provided by:	University of Michigan Cancer Center
ClinicalTrials.gov Identifier:	NCT00148122

Purpose

The purpose of this study is to determine the effectiveness and side effects of a new combination and schedule of chemotherapy drugs in the treatment of head and neck cancer. Patients with advanced or recurrent head and neck cancer, which is untreatable by surgery or radiation therapy are eligible for this study. Standard treatment for advanced or recurrent head and neck cancer involves the use of chemotherapy.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: Docetaxel Drug: Capecitabine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial Evaluating Weekly Docetaxel and Capecitabine in Patients With Metastatic or Advanced, Locally, Recurrent Head and Neck Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Docetaxel Capecitabine

U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:

To measure the overall response rate (complete response and partial response) at 4 months of docetaxel and capecitabine in patients with advanced, locally recurrent or metastatic head and neck cancer. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To measure the grade III/IV toxicities experienced by patients with advanced, locally recurrent, or metastatic head and neck cancer who are treated with docetaxel and capecitabine. [ Time Frame: Throughout the duration of each subject's participation in the treatment phase of the study ] [ Designated as safety issue: Yes ]
To measure the median time to progression of disease in patients with advanced, locally recurrent, or metastatic head and neck cancer who receive docetaxel and capecitabine. [ Time Frame: 9 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	November 2002
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental The purpose of this study is to determine the effectiveness and side-effects of a new combination and schedule of chemotherapy drugs in the treatment of head and neck cancer.	Drug: Docetaxel Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no evidence the disease is getting worse, he/she will continue on the same treatment until: a) there is evidence that the treatment is no longer working to control the growth of his/her disease, b) He/she experiences unacceptable toxicity, c) his/her disease progresses, or d) he/she chooses to stop therapy. Drug: Capecitabine Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no evidence the disease is getting worse, he/she will continue on the same treatment until: a) there is evidence that the treatment is no longer working to control the growth of his/her disease, b) He/she experiences unacceptable toxicity, c) his/her disease progresses, or d) he/she chooses to stop therapy.

Arms

Assigned Interventions

1: Experimental

The purpose of this study is to determine the effectiveness and side-effects of a new combination and schedule of chemotherapy drugs in the treatment of head and neck cancer.

Drug: Docetaxel

Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no evidence the disease is getting worse, he/she will continue on the same treatment until: a) there is evidence that the treatment is no longer working to control the growth of his/her disease, b) He/she experiences unacceptable toxicity, c) his/her disease progresses, or d) he/she chooses to stop therapy.

Drug: Capecitabine

Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no evidence the disease is getting worse, he/she will continue on the same treatment until: a) there is evidence that the treatment is no longer working to control the growth of his/her disease, b) He/she experiences unacceptable toxicity, c) his/her disease progresses, or d) he/she chooses to stop therapy.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy.
Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only).
Patients must be taxane-naïve (no prior docetaxel or paclitaxel).
Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible.
Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration.
Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy.
Aged 18 years or older
Performance status of 0-2 by Zubrod criteria.
Life expectancy of at least 12 weeks.
Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal to or > 8.0 g/dl; platelets equal to or > 100,000/mm3.
Total bilirubin must be within normal institutional limits (WNL).
Transaminases (AST/SGOT and ALT/SGPT) may be up to 2.5 X the institutional upper limit of normal (ULN) if alkaline phosphatase is less than ULN, or alkaline phosphatase may be up to 4 X ULN if transaminases are less than ULN.
A calculated creatinine clearance of > 50 ml/min
Women of childbearing potential must have a negative pregnancy test at baseline, prior to receiving any study drug. (Pregnant or lactating patients are excluded.)
Patients of reproductive potential must practice effective contraception while on study and for at least six months after receiving the last dose of study drug.
All patients must sign an informed consent prior to enrollment.
No prior history of malignancy, except for adequately treated skin cancer or in situ cervical carcinoma or any other cancer in complete remission for at least two years.

Exclusion Criteria:

Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible.
Peripheral neuropathy equal to or greater than grade 2.
Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug.
Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen.
Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.)
Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy.
Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted.
Serious concurrent infections.
Any other serious uncontrolled medical or surgical conditions that the investigator feels might compromise study participation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148122

Locations

United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan Cancer Center

Investigators

Principal Investigator:

Francis Worden, M.D.

University of Michigan Cancer Center

More Information

No publications provided

Responsible Party:	University of Michigan ( Francis P. Worden, M.D. )
Study ID Numbers:	UMCC 2-33
Study First Received:	September 2, 2005
Last Updated:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00148122 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:

Squamous cell cancer of the oral cavity and pharynx

Additional relevant MeSH terms:

Antimetabolites
Docetaxel
Capecitabine
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Head and Neck Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010