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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00113347
Recruitment Status : Completed
First Posted : June 8, 2005
Last Update Posted : February 27, 2012
Aventis Pharmaceuticals
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is 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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Erlotinib Drug: Docetaxel Radiation: Radiation Therapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Evaluation of Erlotinib and Docetaxel With Concomitant Boost Radiation for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck
Study Start Date : April 2005
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Erlotinib + Docetaxel
Erlotinib 100, 125, or 150 mg orally daily except days receive Docetaxel 15 mg/m^2 or 20 mg/m^2 intravenously 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.
Other Names:
  • Tarceva
  • OSI-774
  • Erlotinib Hydrochloride

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.
Other Name: Taxotere

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.
Other Names:
  • XRT
  • Radiotherapy

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of erlotinib and docetaxel during concomitant boost radiation [ Time Frame: 6 weeks of treatment, followed ]
    MTD defined as highest dose level in which 6 patients have been treated with less than or equal to 2 instances of Dose-limiting toxicity (DLT) from 2 sources: 1) Out-of-field toxicity from unirradiated sites secondary to systemic therapy(erlotinib and docetaxel); 2) In-field toxicity from irradiated sites secondary to combined treatment.

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
  2. Patients should have stage III or IV disease, staged T3-4 and/or N2-3, M0
  3. Patients must have a Karnofsky performance status of >= 70
  4. Age >/= 18 years
  5. No hematogenous metastatic disease
  6. 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 <= Upper Limit of Normal (ULN), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) may be up to 2.5 times the upper limit of normal if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4 * ULN if aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) are normal. Patients who have SGPT > 1.5 ULN and alkaline phosphatase > 2.5 * ULN are not eligible.
  7. Creatinine clearance > 50 ml/min determined by 24 hour collection or nomogram: CrCl male = (140 - age) * (weight as kg)/serum Cr * 72 CrCl female = 0.85 * (CrCl male)
  8. Patients must not have received previous surgery, other than diagnostic biopsy, or radiation, for this cancer. Patients may have received neoadjuvant chemotherapy which must have been completed > 3 weeks from beginning therapy on this trial.
  9. 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.
  10. Patients must sign a study-specific informed consent form.
  11. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for 6 months thereafter. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation or bilateral oophorectomy.

Exclusion Criteria:

  1. Histology other than squamous cell carcinoma.
  2. Evidence of metastases (below the clavicle or distant) by clinical or radiographic means.
  3. Karnofsky performance status < 70
  4. Prior therapy with inhibitors of epidermal growth factor receptor (EGFR)
  5. Prior radiotherapy to the head and neck
  6. Patients with simultaneous primaries
  7. 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).
  8. Pregnant/breast-feeding women are ineligible.
  9. Patients refusing or unable to sign the informed consent.
  10. Patients with pre-existing peripheral neuropathy NCI Common Toxicity Criteria (CTC) grade 2 or worse.
  11. Patients with a history of severe hypersensitivity reaction to Taxotere® and/or Polysorbate 80 must be excluded.
  12. Patients may not use ketoconazole, St. John's Wort, or erythromycin.

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 identifier (NCT number): NCT00113347

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Aventis Pharmaceuticals
Genentech, Inc.
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Principal Investigator: Bonnie S. Glisson, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00113347    
Other Study ID Numbers: 2003-1049
First Posted: June 8, 2005    Key Record Dates
Last Update Posted: February 27, 2012
Last Verified: February 2012
Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Squamous Cell Carcinoma
Concomitant Boost Radiation
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Erlotinib Hydrochloride
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors