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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Docetaxel Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

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

Primary Outcome Measures:

Maximum tolerated dose (MTD) of erlotinib and docetaxel during concomitant boost radiation [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	April 2005
Estimated Study Completion Date:	April 2010
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Erlotinib + Docetaxel: 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.

Arms

Assigned Interventions

Erlotinib + Docetaxel: 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.

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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 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.
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. 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:

Histology other than squamous cell carcinoma.
Evidence of metastases (below the clavicle or distant) by clinical or radiographic means.
Karnofsky performance status < 70
Prior 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/breast-feeding women are ineligible.
Patients refusing or unable to sign the informed consent.
Patients with pre-existing peripheral neuropathy 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

Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

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

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T. M.D. Anderson Cancer Center ( Bonnie Glisson, MD/Professor )
Study ID Numbers:	2003-1049
Study First Received:	June 7, 2005
Last Updated:	May 29, 2009
ClinicalTrials.gov Identifier:	NCT00113347 History of Changes
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
Head and Neck Neoplasms
Epidermoid Carcinoma
Carcinoma, Squamous Cell of Head and Neck
Neoplasms, Squamous Cell

Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Protein Kinase Inhibitors
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Erlotinib
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma

Docetaxel
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Therapeutic Uses
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 30, 2009