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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francis (Frank) Worden, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00148122
First received: September 2, 2005
Last updated: March 28, 2014
Last verified: March 2014
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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

Primary Outcome Measures:
  • Overall Response Rate at 4 Months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Disease was assessed by radiologic imaging and RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine response: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.


Secondary Outcome Measures:
  • Frequency of Grade III/IV Toxicities Experienced by Participants [ Time Frame: 30 days post treatment ] [ Designated as safety issue: Yes ]
    The frequency of grade 3 and grade 4 adverse events experienced by all treated participants.

  • Probability of Progression Free Survival [ Time Frame: 1 year post treatment ] [ Designated as safety issue: No ]
    The estimated 1 year progression free survival. Progression was defined, using RECIST (Response Evaluation Criteria In Solid Tumors Criteria), as a 20% increase in the sum of the longest diameter of target lesions, the development of any new lesion, or the significant clinical deterioration related to the progression of patient's disease. The probability of progression-free survival was presented in a Kaplan-Meier curve to illustrate the distribution of progression time. The median time to progression was determined with a 95% CI (Confidence Interval).


Enrollment: 40
Study Start Date: November 2002
Study Completion Date: July 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)
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.
Other Name: US Brand Name: Taxotere
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.
Other Name: US Brand Name(s): Xeloda

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Francis (Frank) Worden, Principal Investigator, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00148122     History of Changes
Other Study ID Numbers: UMCC 2-33, Legacy IRBMED 2002-747
Study First Received: September 2, 2005
Results First Received: February 13, 2014
Last Updated: March 28, 2014
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:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Capecitabine
Docetaxel
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014