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Erlotinib and Docetaxel With Concomitant Boost Radiation Therapy (XRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, June 2008

Sponsors and Collaborators: M.D. Anderson Cancer Center
Aventis Pharmaceuticals
Genentech
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00113347
  Purpose

Patients will receive 6 weeks of treatment. On days 1, 8, 15, and 22, they will receive 15 mg/m2 or 20 mg/m2 docetaxel. On all other days (i.e., days on which the patient does not receive docetaxel), the patient will take 100, 125, or 150 mg of erlotinib.

Patients will also receive radiation therapy beginning on day 1 of treatment. Treatment will be delivered in 40 fractions. During weeks 1-3, patients will receive XRT once daily 5 times per week (Monday through Friday). The patient will not receive treatment on weekends. The target dose depends upon the target volume. During weeks 4-6, patients will receive their treatment in fractions with a minimum of 6 hours between radiation treatments.


Condition Intervention Phase
Head and Neck Cancer
Drug: Erlotinib
Drug: Docetaxel
Radiation: Radiation Therapy
Phase I

MedlinePlus related topics:   Cancer    Head and Neck Cancer   

ChemIDplus related topics:   Docetaxel    Erlotinib    Erlotinib hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase I Evaluation of Erlotinib and Docetaxel With Concomitant Boost Radiation for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To find the highest safe dose of the drugs OSI-774 and docetaxel that can be given together along with radiation treatment for advanced head and neck cancer. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • This research will also look at how participants respond to this treatment and the side effects they experience while on it. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]
  • Assess response to treatment, time to local, regional, and distant failure, and overall survival [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
  • Also study the effect of swallowing function before treatment and in the follow-up period. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
  • Optional Procedure: to provide an additional blood sample that will be stored in a tissue bank. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:   24
Study Start Date:   April 2005
Estimated Primary Completion Date:   April 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Erlotinib and Docetaxel with Concomitant Boost Radiation to Head/Neck
Drug: Erlotinib
Beginning on Day 2 of treatment, 100, 125, or 150 mg by mouth once a day every day while on treatment, except on days docetaxel is received.
Drug: Docetaxel
15 mg/m^2 or 20 mg/m^2 by vein over 15 to 30 minutes on Days 1, 8, 15, and 22 of treatment.
Radiation: Radiation Therapy
Radiation therapy to head/neck beginning on day 1 of treatment once daily 5 times per week (Monday through Friday), delivered in 40 fractions.

Show detailed description  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 with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
  • Patients should have stage III or IV disease, staged T3-4 and/or N2-3, M0
  • Patients must have a Karnofsky performance status of >/= 70.
  • Age >/= 18 years.
  • No hematogenous metastatic disease.
  • Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 1500 cells/mm^3 and platelet count of > 100,000 cells/mm^3; adequate hepatic function with total bilirubin </= ULN, SGOT and SGPT may be up to 2.5 times the upper limit of normal if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4x ULN if SGPT and SGOT are normal. Patients who have SGPT > 1.5 ULN and alkaline phosphatase > 2.5 x ULN are not eligible.
  • Creatinine clearance > 50 ml/min determined by 24 hour collection or nomogram:

    • CrCl male = (140 - age) x (wt. as kg)/serum Cr x 72;
    • CrCl female = 0.85 x (CrCl male).
  • Patients must not have received previous treatment (surgery, radiation, or chemotherapy) except biopsy for the tumor under study.

Patients with a history of non-melanoma skin cancer, or other previous malignancies treated 5 years or more prior to the current tumor from which the patient has remained continually disease-free, are eligible.

  • Patients must sign a study-specific informed consent form.
  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for 6 months thereafter.

Exclusion Criteria:

  • Histology other than squamous cell carcinoma.
  • Evidence of metastases (below the clavicle or distant) by clinical or radiographic means.
  • Karnofsky performance status < 70
  • Prior chemotherapy or therapy with inhibitors of EGFR
  • Prior radiotherapy to the head and neck
  • Patients with simultaneous primaries.
  • Patients with a past history of malignancy (excluding non melanoma skin cancers, and cancers treated > 5 years prior for which patient remains continuously disease free).
  • Pregnant or breastfeeding women are ineligible.
  • Patients refusing or unable to sign the informed consent.
  • Patients with pre-existing peripheral neuropathy National Cancer Institute Common Toxicity Criteria (NCI CTC) grade 2 or worse.
  • Patients with a history of severe hypersensitivity reaction to Taxotere® and or polysorbate 80 must be excluded.
  • Patients may not use ketoconazole, St. John's Wort, or erythromycin.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113347

Contacts
Contact: Bonnie S. Glisson, MD     713-792-6363    

Locations
United States, Texas
MD Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Contact: Bonnie Glisson, MD     713-792-6363     bglisson@mdanderson.org    
      Contact: Louise Christmas, RN     713-745-6760     lchristmas@mdanderson.org    
      Principal Investigator: Bonnie S. Glisson, MD            
      Sub-Investigator: Adam Garden, MD            

Sponsors and Collaborators
M.D. Anderson Cancer Center
Aventis Pharmaceuticals
Genentech

Investigators
Principal Investigator:     Bonnie S. Glisson, MD     U.T. M.D. Anderson Cancer Center    
  More Information


Responsible Party:   U.T. M.D. Anderson Cancer Center ( Bonnie Glisson, MD/Professor )
Study ID Numbers:   2003-1049
First Received:   June 7, 2005
Last Updated:   June 11, 2008
ClinicalTrials.gov Identifier:   NCT00113347
Health Authority:   United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer  
Squamous Cell Carcinoma  
Erlotinib  
Docetaxel  
Radiation
Radiotherapy
Concomitant Boost Radiation

Study placed in the following topic categories:
Erlotinib
Docetaxel
Epidermoid carcinoma
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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