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Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck

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ClinicalTrials.gov Identifier: NCT00216138
Recruitment Status : Terminated (Interim analysis results did not meet criteria for second stage of trial)
First Posted : September 22, 2005
Last Update Posted : May 2, 2011
Sponsor:
Collaborators:
Sanofi
Hoffmann-La Roche
Walther Cancer Institute
Information provided by:
Hoosier Cancer Research Network

Brief Summary:

Recent progress in treatment of recurrent/metastatic SCCHN has been made with the introduction of the taxanes. Docetaxel as a single agent has a response rate of 22-42% and 17% in patients with recurrent disease. Capecitabine is an oral fluoropyrimidine prodrug that is converted into 5-FU. Previous studies have shown that the capecitabine/docetaxel combination has a synergistic inhibition of tumor growth, resulting in significantly superior efficacy in time to disease progression (TTP), overall survival, median survival and objective tumor response rate compared to docetaxel alone.

This trial will investigate the efficacy the combination of docetaxel and capecitabine in treating patients with recurrent/metastatic SCCHN.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Docetaxel Drug: Capecitabine Drug: Premedication Phase 2

Detailed Description:

OUTLINE: This is a multi-center study.

  • Dexamethasone and antiemetic premedication1.
  • Docetaxel: 60 mg/m2 for a 60 minute infusion day 1 of each cycle
  • Capecitabine: 825 mg/m2 po BID Days 1-14

Repeat every 21 days until tumor progression or toxicity that requires discontinuation of therapy

Performance status: ECOG performance status 0 or 1

Life expectancy: At least 3 months

Hematopoietic:

  • ANC of > 1,500/mm3
  • Platelets > 100,000/mm3
  • Hemoglobin > 8 gm/dl

Hepatic:

  • Total Bilirubin £ ULN
  • Albumin > 3
  • Maximum Alk Phos > 2.5 x < 5 x ULN

Renal:

  • Creatinine clearance of > 50 ml/ min (by Cockcroft-Gault)

Cardiovascular:

  • No decompensated congestive heart failure or active angina.
  • Clinically significant cardiac disease not well controlled with medication (eg. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction in the past 12 months is not allowed.

Pulmonary:

  • Not specified

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Single Arm Phase II Trial of Docetaxel and Capecitabine for the First Line Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN): Hoosier Oncology Group HN02-40
Study Start Date : March 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
Docetaxel + Capecitabine
Drug: Docetaxel
Docetaxel 60 mg/m2 for 60 minutes, day 1 of each cycle

Drug: Capecitabine
Capecitabine 825 mg/m2 po bid, days 1-14

Drug: Premedication
Dexamethasone and antiemetic premedication




Primary Outcome Measures :
  1. - To assess response rate in a group of patients receiving combination therapy with docetaxel and capecitabine [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. To assess toxicity of the combination [ Time Frame: 24 months ]
  2. To determine whether the status of calpain, calpain activation,(EGFR) expression, Cox-2 expression, TS, TP, DPD, and/or CYP3A4/CYP3A5 will predict treatment [ Time Frame: 24 months ]
  3. Efficacy and safety analyses on special sub-cohorts [ Time Frame: 24 months ]
  4. To determine the progression free survival and overall survival [ Time Frame: 24 months ]
  5. To assess change in analgesic usage with this protocol therapy [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck.
  • Recurrent/metastatic disease not amenable to surgery or salvage chemoradiation.
  • Unidimensional measurable disease according to the RECIST
  • In-field recurrence, within a prior radiation field only, distant metastatic disease
  • Both in-field and metastatic sites of disease will require evaluation by a Radiation Oncologist to consider local radiation therapy first and will be eligible for possible enrollment one month after completion of the radiation therapy.
  • Negative pregnancy test
  • Patients may have received prior chemotherapy as part of chemoradiation or induction chemotherapy for initial treatment of disease confined to the head and neck region - Patients must have fully recovered from any prior radiation therapy

Exclusion Criteria:

  • Patients who have relapsed < 6 months after completing a combined modality curative treatment that included a fluoropyrimidine or taxanes
  • No brain metastases
  • No major neurological disease, including stroke
  • No prior chemotherapy regimen for recurrent/metastatic disease
  • No prior history of capecitabine usage
  • No prior history of docetaxel usage except in the induction setting for head and neck cancer which has been completed for greater than 6 months prior to beginning protocol therapy
  • No past hypersensitivity to taxanes or 5 FU
  • No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
  • No current use of warfarin
  • Patients must not be receiving ketoconazole, midazolam, erythromycin, orphenadrine, troleandomycin, cyclosporine or antiepileptics
  • Patients must not be treated with any of the following on protocol therapy or within 28 days prior to beginning protocol therapy: sorivudine, brivudine, cimetidine, allopurinol
  • Patients must have fully recovered from any prior surgery
  • No known HIV seropositivity.
  • No serious uncontrolled medical condition, uncontrolled peptic ulcer disease or malabsorption syndrome
  • No peripheral neuropathy > grade 1
  • Patients with a percutaneous gastrostomy (PEG) must be able take medications by tube.
  • No daily consumption of alcohol
  • No active infection
  • No prior history of malignancy in the last 5 years, excluding in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin or Gleason Grade < VII organ confined prostate cancer.
  • No current breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216138


Locations
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United States, Delaware
Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Elkhart Clinic
Elkhart, Indiana, United States, 46515
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46527
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, United States, 46202
Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
Center for Cancer Care, Inc., P.C.
New Albany, Indiana, United States, 47150
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
Providence Medical Group
Terre Haute, Indiana, United States, 47802
AP&S Clinic
Terre Haute, Indiana, United States, 47804
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Center for Hematology-Oncology of S Michigan
Jackson, Michigan, United States, 49201
United States, Missouri
Siteman Cancer Center
St. Louis, Missouri, United States, 63110
United States, Nebraska
Methodist Cancer Center
Omaha, Nebraska, United States, 68114
Sponsors and Collaborators
Hoosier Cancer Research Network
Sanofi
Hoffmann-La Roche
Walther Cancer Institute
Investigators
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Study Chair: David Potter, M.D. Hoosier Oncology Group, LLC

Additional Information:
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Responsible Party: David Potter, M.D., Hoosier Oncology Group
ClinicalTrials.gov Identifier: NCT00216138     History of Changes
Other Study ID Numbers: HOG HN02-40
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: April 2011
Keywords provided by Hoosier Cancer Research Network:
Head and Neck Cancer
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites