Active clinical trials for "Head and Neck Neoplasms"

We propose to combine lapatinib with RT alone in patients with locally advanced head and neck cancer who cannot tolerate chemotherapy. The main objective of the study is to determine the efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression (TTP) in this group of patients. In addition, we will determine the 2-year locoregional control rate (LRC), progression-free survival (PFS) and overall survival (OS) in these patients. We will also evaluate the profile and frequency of late toxicity, specifically mucosal and dermatologic toxicity, of the combination of lapatinib and RT in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

Primary Objective: To determine if amifostine in combination with IMRT can mitigate the decrease in production of saliva by the submandibular and sublingual salivary glands in patients with HNSCC. Secondary Objectives: To establish a parotid gland dose volume histogram (DVH) versus measured flow relationship in this patient population: When the mean dose is < 24-26 Gy (shift recovery time to left) When the mean dose is > 24-26 Gy (DVH shift) To observe mucositis in the following lower dose RT areas: Upper lip Lower lip Right cheek Left cheek Right ventral and lateral tongue Left ventral and lateral tongue Floor of the mouth Soft palate Hard palate. To observe the incidence and patterns of occipital scalp epilation; To observe the incidence of dysphagia using the List Performance Status Scale (LPSS); and To further evaluate the safety profile of amifostine in this patient population.

Metformin plus paclitaxel for recurrent or metastatic head and neck cancer: a randomized phase II trial

The combination of oxaliplatin and gemcitabine is highly active in a wide variety of tumors including pancreatic, germ cell, breast, biliary, mesothelioma (Mitchell et al, 2002), and lung. In the last study which utilized days 1 and 8 gemcitabine 1000 mg/m2 and days 1 and 8 oxaliplatin 65 mg/m2 in poor prognosis lung cancer patients (PS 1-3) the response rate was 16% with no incidence of febrile neutropenia. Toxicity is a crucial consideration when designing regimens intended for palliation. Toxicities associated with cisplatin can make it difficult to use in patients with Head and Neck Cancer (HNC), many of whom are elderly and have comorbidities. In addition, many patients with metastatic HNC have previously received cisplatin during neoadjuvant/adjuvant therapy, or as part of their primary chemoradiation treatment. When these patients recur, it is possible their tumors have innate or acquired cisplatin resistance. Oxaliplatin is likely to be better tolerated than cisplatin containing regimens, especially with regards to neurotoxicity. Gemcitabine has shown promising activity as a single agent and in combination chemotherapy in the first line treatment of patients with HNC. A combination chemotherapy regimen using oxaliplatin and gemcitabine administered once every week is logical and worth exploring in patients with metastatic and recurrent head and neck cancer to improve the toxicity profile and patient monitoring while maintaining efficacy of the chemotherapy regimen.

The primary objective of this study is to estimate the modulation of intermediate biological endpoints of the combination of 4-HPR and SCH66336, a farnesyl transferase inhibitor (FTI), across 4 randomly assigned dose levels in patients with locally advanced or recurrent head and neck cancer. We will also assess the activity, safety, tolerability and side effects of 4-HPR/SCH66336 and hope to establish a phase II regimen.

This study seeks to establish the safety of gemcitabine, paclitaxel and low-dose radiation in recurrent, metastatic head and neck cancer through a two-stage dose escalation study, first with Gemcitabine dose escalation and then with low-dose radiation escalation. Treatment Schedule Treatment will be administered on an inpatient or outpatient basis. Gemcitabine:2000 to 3000mg/m2 IV (in the vein) on days 1 and 15 every 28 days over 30-60 minutes. Paclitaxel: 150 mg/m2 IV(in the vein)on days 1 and 15 every 28 days over 60 minutes. Low Dose Radiation: 50-80 cGy twice daily on days 1, 2, 15, & 16 every 28 days at least 4 hours apart.

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may help prevent or treat cancer-related anemia. It is not yet known whether radiation therapy is more effective with or without epoetin alfa in treating head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating patients who have head and neck cancer.

Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining docetaxel with gefitinib may kill more tumor cells. It is not yet known whether docetaxel is more effective with or without gefitinib in treating head and neck cancer. This randomized phase III trial is studying docetaxel and gefitinib to see how well they work compared to docetaxel alone in treating patients with metastatic or locally recurrent head and neck cancer.

To derive the maximum tolerated dose of hypofractionated stereotactic body radiotherapy (SBRT) using dose painting by numbers with immunomodulating systemic therapy in patients that are reirradiated for recurrent squamous cell carcinoma of the head and neck.

Referred otalgia is one of the symptoms of oropharynx and hypopharynx cancer. It can be primary (otodynia) or secondary (referred otalgia and projected pain). The mechanism of referred otalgia involves several non adjacent nerve territories as those of head, neck or ear. Referred otalgia is a projected pain due to injury (most of the time cancer) localized far from the ear but sharing the same innervation. In this contest, the otoscopy is normal. Four cranial nerves participate in the sensory innervation of the external ear: the trigeminal nerve (V) via the auriculo temporal nerve (V3), the facial nerve (VII) for the Ramsay-Hunt's zone with the conch, tragus, antitragus, a part of the anthelix, of the external auditory meatus and of the eardrum, the glossopharyngeal nerve (IX) via the Jacobson's nerve for the external ear canal and the C2 and C3 cervical plexus. However, there are important interindividual anatomical variations. The relationship between referred otalgia and probable nerve damage has been described. In he oropharynx and hypopharynx, the proximity of the sensory innervation of the ear can then explain the otalgia during the cancer progression. Then referred otalgia has a neuropathic component. In the literature, the curative treatment of referred otalgia is the cancer treatment. However, the high intensity of referred otalgia leads the patients to a large consumption of analgesics in particular of opioids. These latter are particularly adapted for pain resulting from excess of nociceptive stimulation. Pregabalin (Lyrica®) is an analogue of gamma aminobutyric acid. This molecule binds to alpha subunit 2 delta 1 calcium dependent voltage channels in the central nervous system. its effectiveness has been demonstrated for the treatment of neuropathic pain on diabetic neuropathy, post herpetic neuralgia, lesions in the bone marrow but also the postoperative pain when the molecule is administered after the surgery. The anti hyperalgesic activity of pregabalin is at a dosage of 150mg/day in two or three daily doses. The purpose of this study was to evaluate the activity of pregabalin administered orally for three weeks after the anesthesia consultation on the intensity of the pain of referred otalgia and on its neuropathic component.