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

NCT00148122 | Completed Phase 2 Results DMC

• 2 other identifiers: UMCC 2-33Legacy IRBMED 2002-747
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

Squamous cell cancer of the oral cavity and pharynx

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate at 4 Months

  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.

  4 months

Secondary Outcomes (2)

• Frequency of Grade III/IV Toxicities Experienced by Participants

  30 days post treatment

• Probability of Progression Free Survival

  1 year post treatment

Study Arms (1)

Arm 1

EXPERIMENTAL

Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, \&15)

Drug: Docetaxel; Drug: Capecitabine

Interventions

Docetaxel DRUG

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.

Also known as: US Brand Name: Taxotere

Arm 1

Capecitabine DRUG

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.

Also known as: US Brand Name(s): Xeloda

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Docetaxel; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Francis Worden
• Organization: University of Michigan Comprehensive Cancer Center

fworden@umich.edu

734-936-0453

Study Officials

• Francis Worden, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: September 2, 2005
• First Posted: September 7, 2005
• Study Start: November 1, 2002
• Primary Completion: August 1, 2008
• Study Completion: July 1, 2010
• Last Updated: April 17, 2014
• Results First Posted: March 28, 2014

Record last verified: 2014-03

Locations

US (1)