Head and Neck Cancer Clinical Trial
Official title:
Phase I/II Study on Induction Chemotherapy Followed by Chemoradiation With or Without Lapatinib, a Dual EGFR/ErbB2 Kinase Inhibitor, in Patients With Locally Advanced Larynx and Hypopharynx Squamous Cell Carcinoma
Verified date | July 2018 |
Source | European Organisation for Research and Treatment of Cancer - EORTC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and
carboplatin, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill
tumor cells. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Giving combination chemotherapy together with radiation therapy, with
or without lapatinib, before surgery may make the tumor smaller and reduce the amount of
normal tissue that needs to be removed or eliminate the need for surgery.
PURPOSE: This phase I/II trial is studying the side effects and best dose of combination
chemotherapy given together with radiation therapy with or without lapatinib and to see how
well it works in treating patients with locally advanced cancer of the larynx or hypopharynx.
Status | Completed |
Enrollment | 7 |
Est. completion date | March 2009 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed squamous cell carcinoma of the larynx or hypopharynx - T3 or T4 disease of the larynx or T2, T3 or T4 disease of the hypopharynx - Nodal status must be N0, N1, N2a, N2b, N2c or N3 - Resectable or unresectable disease (Phase I patients only) - Patient must have tumors amenable to surgery (Phase II patients only) - No distant metastasis PATIENT CHARACTERISTICS: - WHO performance status 0-2 - Absolute neutrophil count = 1,500/mm³ - Platelet count = 100,000/mm³ - Bilirubin < 1.5 times the upper limit of the normal range - Alkaline phosphatase and transaminases < 2.5 times the upper limit of the normal range - Serum creatinine < 1.7 mg/dL - All patients (male and female) must use effective contraception methods if of reproductive potential (e.g., implants, injectables, combined oral contraceptives, IUDs, sexual abstinence, or vasectomized partner) - Females must not be pregnant or lactating - Patients must have normal cardiac function (LVEF assessed by MUGA or ECHO) and clinically satisfactory 12-lead ECG - No serious cardiac illness or medical condition within the past 6 months including, but not limited to, any of the following: - History of documented congestive heart failure - High-risk uncontrolled arrhythmias - Angina pectoris requiring antianginal medication - Clinically significant valvular heart disease - Evidence of transmural infarction on ECG - Poorly controlled hypertension (e.g., systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg) - Patients should be able to swallow oral agents - No current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma or other cancer from which the patient has been disease-free for at least five years - Absence of any unstable systemic diseases or active uncontrolled infections - Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: - No other prior therapy for head and neck cancer - More than 10 days since prior and no concurrent CYP3A4 inducers, including the following: - Antibiotics (e.g., all rifamycin class agents [rifampicin, rifabutin, or rifapentine]) - Anticonvulsants (e.g., phenytoin, carbamezepine, or barbiturates [phenobarbital]) - Oral glucocorticoids (e.g., cortisone [> 50 mg], hydrocortisone [> 40 mg], prednisone [> 10 mg], methylprednisolone [> 8 mg], or dexamethasone [> 1.5 mg]) - Antiretrovirals (e.g., efavirenz or nevirapine) - Other (hypericum perforatum [St. John's Wort] or modafinil) - More than 10 days since prior and no concurrent CYP3A4 inhibitors, including the following: - Antibiotics (e.g., clarithromycin, erythromycin, or troleandomycin) - Antifungals (e.g., itraconazole, ketoconazole, fluconazole [> 150 mg daily], or voriconazole) - Antiretrovirals and protease inhibitors (e.g., delavirdine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, or lopinavir) - Calcium channel blockers (e.g., verapamil or diltiazem) - Antidepressants (e.g., nefazodone or fluvoxamine) - Gastrointestinal agents (e.g., cimetidine or aprepitant) - Other (e.g., grapefruit, grapefruit juice, or camiodarone) - Miscellaneous (e.g., antacids [Mylanta, Maalox, Tums, or Rennies], all herbal [bergamottin or glabridin] or dietary supplements) - Patients may not receive any other anticancer therapy or investigational agents while on study |
Country | Name | City | State |
---|---|---|---|
Belgium | Institut Jules Bordet | Brussels |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
Belgium,
Lalami Y, Specenier PM, Awada A, Lacombe D, Liberatoscioli C, Fortpied C, El-Hariry I, Bogaerts J, Andry G, Langendijk JA, Vermorken JB. EORTC 24051: unexpected side effects in a phase I study of TPF induction chemotherapy followed by chemoradiation with — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose of lapatinib ditosylate (Phase I) | |||
Primary | Dose-limiting toxicities of lapatinib ditosylate (Phase I) | |||
Primary | Recommended dose of lapatinib ditosylate (Phase I) | |||
Primary | Feasibility (Phase II) | |||
Secondary | Toxicity (Phase II) | |||
Secondary | Survival with functional larynx (i.e., alive without local progression/relapse, tracheotomy, feeding tube, gastrostomy, or laryngectomy) (Phase II) | |||
Secondary | Response rate (CR and PR) of neoadjuvant treatment (Phase II) | |||
Secondary | Overall response rate (Phase II) | |||
Secondary | Rate of local relapse (Phase II) | |||
Secondary | Distant metastasis (Phase II) | |||
Secondary | Overall survival (Phase II) | |||
Secondary | Predictive value of PET to spare neck dissection in N1-3 patients (Phase II) |
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