Docetaxel and Carboplatin with or without Low Dose Radiation Therapy in Treating Patients with Previously Untreated Locally Advanced Head and Neck Cancer

Status: closed to accrual and intervention

This randomized phase II trial studies how well docetaxel and carboplatin with low dose radiation therapy works compared with docetaxel and carboplatin alone in treating patients with head and neck cancer that has spread to nearby tissues or organs (locally advanced) and is previously untreated. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors, and may also make tumor cells more sensitive to chemotherapy. It is not yet known whether giving docetaxel and carboplatin with radiation therapy may kill more tumor cells.

Inclusion Criteria

Patients must have histologically or cytologically confirmed locally advanced head and neck cancer of squamous type stage III, IVA and IV B (larynx, oral cavity, oropharynx and hypopharynx or unknown primary isolated to the head and neck region) and select stage II tumors of the base of the tongue (BOT) (size more than 3 cm), who are appropriate for potentially curative therapy with chemoradiotherapy or surgical resection, as determined by the multidisciplinary head and neck cancer clinical care and research team
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam; all disease must be assessed within 28 days prior to registration
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
No prior chemotherapy for the current locally advanced squamous cell carcinoma of the head and neck (SCCHN); prior radiation or chemotherapy for a previous head and neck cancer is allowed provided full dose radiation can be delivered to the current treatment and provided the patient remains in remission for greater than 3 years from prior diagnosis
Life expectancy of greater than 3 months
Within 14 days of registration: Absolute neutrophil count >= 1,000/mcL
Within 14 days of registration: Platelets >= 100,000/mcL
Within 14 days of registration: Total bilirubin < institutional upper limit of normal
Within 14 days of registration: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 1.5 x institutional upper limit of normal
Within 14 days of registration: Alkaline phosphatase =< 2.5 × institutional upper limit of normal
Within 14 days of registration: Creatinine within normal institutional limits OR
Within 14 days of registration: Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, throughout the duration of active treatment and for 4 months after completion of chemotherapy and radiation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of active study treatment, and for 4 months after completion of chemotherapy and radiation (both induction and definitive) administration
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Prior chemotherapy for the current SCCHN will not be allowed; patients with second primary cancers of the head and neck who remain in remission for 3 years from the prior diagnosis are eligible for this study, provided they may receive full dose radiation to the current SCCHN cancer
Patients who are receiving any other investigational agents
Patients with known brain metastases should be excluded from this clinical trial
History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin or docetaxel
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with these agents and/or radiation
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated previous stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 3 years
Patients with nasopharynx or salivary gland primary site will be excluded from this trial
Patients with distant metastatic disease (M1c) will not be eligible for this study
Patients with grade II or greater peripheral neuropathy will be excluded from study

PRIMARY OBJECTIVES:

I. To assess the primary site complete response rate of patients treated with 2 cycles of induction docetaxel and carboplatin with low dose fractionated radiation therapy (LDFRT) compared to those treated with chemotherapy alone.

SECONDARY OBJECTIVES:

I. To assess overall response rate of patients to 2 cycles of induction docetaxel and carboplatin with or without LDFRT.

II. To assess the toxicity and quality of life (QOL) of LDFRT with chemotherapy compared to chemotherapy alone in this patient population.

III. To assess the 3-year overall survival of patients treated with this regimen.

IV. To assess measures of deoxyribonucleic acid (DNA) repair (gamma-H2A histone family, member X [H2AX] levels, poly (adenosine diphosphate [ADP]-ribose) polymerase 1 [PARP] activation) and DNA repair kinetics (comet assay) in serial mucosal cell samples obtained from the irradiated region of the head and neck (i.e. buccal, tongue, pharyngeal wall, etc.) of subjects on this trial.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive docetaxel intravenously (IV) over 60 minutes and carboplatin IV over 30 minutes on day 1 and undergo LDFRT twice daily (BID) at least 3 hours apart on days 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive docetaxel and carboplatin as in Arm I. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Patients in both Arms are reassessed at least 2 weeks after the last LDFRT and then undergo definitive radiation therapy and receive chemotherapy per standard of care.

After completion of study treatment, patients are followed up for 3 years.

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Docetaxel and Carboplatin with or without Low Dose Radiation Therapy in Treating Patients with Previously Untreated Locally Advanced Head and Neck Cancer

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