Active clinical trials for "Lung Neoplasms"

BACKGROUND Platinum-based chemotherapy (CT) is the standard treatment for advanced non-small-cell lung cancer (NSCLC). Unfortunately, the survival and response rate (RR) to CT is poor. There is great interest in new treatment strategies. One of this new strategies include the use of retinoids such as atRA. The synergistic effect of cytotoxic agents with retinoids has been demonstrated in lung cancer. At the INCan, our work group carried out a phase II study trial that included 107 patients with advanced NSCLC. They were randomized to receive atRA (20-mg/m2) or placebo combined with 80 mg/m2 of cisplatin and 175 mg/m2 of paclitaxel. The results showed a significant increase in the RR of the atRA group, reaching 55.8% ( 95% CI; 46.6-64.9%) compared with 25.4% (95% CI, 21.3-29.5%; p = 0.001) in patients who received placebo. Median Progression-free survival (PFS) in the atRA group was 8.9 months, while for those of placebo, PFS was 6.0 months (p = 0.008). There were no significant differences in the grade 3-4 side effects between groups, except for hypertriglycemia, which presented with greater frequency in the atRA group (p = 0.05). Immunohistochemical stains determine the RAR B2 expression in 6 of 60 tumor samples analyzed; however, all samples expressed RAR B2 in adjacent normal tissue. HYPOTHESIS Patients with NSCLC who receive the scheme combined with first-line CT plus 45 mg/m2 of atRA will have a greater PFS and RR to CT with an acceptable toxicological profile. OBJECTIVES Obtain a greater RR to CT and PFS in patients with advanced NSCLC who receive cisplatin- and paclitaxel-based CT combined with a 45-mg/m2 daily dose of atRA with an acceptable toxicological profile . Evaluate the benefit of RAR beta and RAR alfa expression as a response biomarker. METHODS Three hundred and thirty patients with advanced NSCLC will be included to receive Paclitaxel 175 mg/m2 and Cisplatin 80 mg/m2 (PC) every 21 days for 6 cycles. Patients will be randomized to receive ATRA 45 mg2/day or placebo 1 week before treatment until completing six cycles. Imaging studies will be performed prior and after two cycles of CT to assess response. RAR beta and RAR alfa expression will be analyzed by immunohistochemistry in lung tumoral tissue and in the adjacent lung tissue.

Vitamin D exerts antiproliferative and differentiating effects in cancers, including non-small cell lung cancer (NSCLC). The active form of Vitamin D is 1,25, dihydroxycholecalciferol (calcitriol) which rapidly induces expression of cytochrome P450 24R-hydroxylase (CYP24A1). CYP24A1 initiates inactivation of calcitriol as a result of successive hydroxylation/oxidation reactions. This study seeks to prospectively determine the relationship between Vitamin D gene expression and median survival as a primary outcome, and between the Vitamin D receptor (VDR)/CYP24A1 gene expression and cancer stage, smoking status, serum 1,25 (OH)2D3 levels as well as CYP24A1 genotype.

Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.

Cetuximab, erlotinib, and panitumumab are all recently FDA approved epidermal growth factor receptor (EGFR) inhibitors that treat a wide variety of tumor types, such as colon, lung, and head and neck. Blockade of the EGFR results in inhibition of multiple downstream pathways, leading to slowed tumor growth. In addition, these inhibitors may enhance anti-tumor immune responses through uncharacterized mechanisms. While producing significant responses in many settings, EGFR inhibitors also result in significant skin toxicity (rash) in a high percentage of patients. Multiple studies have correlated the presence and severity of rash with clinical response. Unfortunately, severe rash can often lead to dose delays, reductions, or even discontinuation of EGFR inhibitors, thus limiting their efficacy. The mechanism of both the rash and its correlation with tumor response is poorly understood. Skin biopsies display a robust leukocyte infiltrate, but a systematic analysis of the type of infiltrating leukocytes, activation state, or homing receptor expression has not been performed. Chemokines and chemokine receptors control leukocyte trafficking to the skin and other tissue sites, and defined receptor profiles for skin-, gut-, and lung-homing leukocytes are well established. In this study, the investigators propose to evaluate the homing phenotype of leukocytes from peripheral blood and skin biopsies of patients receiving EGFR inhibitors. The investigators will use RNA microarrays to evaluate the expression of chemokines and other key genes regulated in skin during treatment. The investigators will utilize in vitro methods to investigate effects of EGFR inhibitors on imprinting of T cell tissue-specific homing receptors. The investigators will examine correlations among the pathologic data, clinical findings, and tumor response. If validated, peripheral blood evaluation could potentially be used as a predictive indicator for patients receiving EGFR inhibitors. This study may also identify novel targets for limiting skin toxicity while receiving EGFR inhibitors, thus allowing maximal dosing and clinical response from these agents.

The purpose of this study is to assess the short and long-term outcomes after CyberKnife stereotactic radiosurgery for early stage non-small cell lung cancer (NSCLC) in patients who are medically inoperable.

The aim of this study is to assess the superiority of docetaxel in comparison to erlotinib in second line in wild-type EGFR tumour patients.

This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and toxicity of erlotinib in patients with asymptomatic brain metastasis advanced NSCLC who was benefitted by first line chemotherapy. Patients with stage IV NSCLC who have one or more asymptomatic brain metastasis who was benefitted by first line chemotherapy will receive oral erlotinib 150mg once daily until disease progression or unacceptable toxicity. These patients' direct DNA sequencing of tumor tissue EGFR exons 18-21 will be analyzed The response was evaluated by RECIST criteria after the patient received erlotinib 6 weeks.If the patients present with progress disease of brain metastasis after the therapy of erlotinib, the patients will receive irradiation of brain metastasis.If the response is stable disease,partial response or complete response,he will be examined by brain MRI every 12 weeks.

The purpose of the study is to determine whether the combination of talactoferrin, carboplatin and paclitaxel improves progression free survival and overall survival in patients with non-small cell lung cancer compared to the combination of paclitaxel and carboplatin alone

This is a two-part study. Part I is an observational study. Part II is a randomized clinical trial to see how well medical nutrition therapy works compared with standard care in treating patients with lung cancer, pancreatic cancer, or stage III or stage IV prostate cancer.

The purpose of this study is to examine the feasibility of video-assisted thoracoscopic surgery (VATS) major pulmonary resection with systematic node dissection (SND) for clinical stage IIIA non-small cell lung cancer. Success is defined as VATS major pulmonary resection with SND without conversion. If success rate over 90%, VATS major pulmonary resection with SND is considered as feasible procedures for clinical stage IIIA non-small cell lung cancer.