Disease- Area Surgical Oriented Research
Disease-Oriented Research – Urogenital Tumors
Research Activities
Prostate Cancer Our research activity on prostate cancer addresses the issues commonly encountered by the practicing oncologists. The research themes include: - Development of surrogate markers that may have utility in predicting prognosis and monitoring the antitumor effects of treatment in castration-resistant prostate cancer. - Clinical trials addressing new drugs in patients with prostate cancer. - Clinical trials including biological agents targeting different critical points of the signaling cascade or proteins of the mitotic machine. Despite its limitations, PSA is the best tumor marker of prostate cancer currently available in clinical practice. We are developing an alternative biomarker strategy, testing the prognostic and predictive value of Circulating Tumor Cells (CTCs) in prostate cancer, using the CellSearch System®, approved by the FDA for routine clinical use in metastatic breast cancer, colorectal cancer and in castration-resistant prostate cancer (CPRC). We investigated the role of CTCs in: • Patients with CRPC who are starting first or second line systemic treatment for advanced disease. (manuscript in preparation). • Patients with clinically localized prostate cancer eligible for radical prostatectomy (clinical stage T13NxM0, any Gleason score) with the aim to investigate the prognostic value of CTCs before and after curative treatments, the correlation between CTCs and other known prognostic factors and biomarkers. • Patients with PSA failure, following definitive treatment of prostate cancer.
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IEO — Scientific Report 2012 — Ongoing Research 2013
Ongoing Clinical Trials: • A Phase III study, evaluating Dasatinib, a potent orally active tyrosine kinase inhibitor, or placebo in combination with Docetaxel/prednisone in castrationresistant prostate cancer. This study completed the accrual in 2012. • A phase III double bind, placebo controlled efficacy and safety study evaluating MDV3100 in patients with progressive castration resistant prostate cancer who have previously treated with docetaxel-based chemotherapy. Renal cancer Ongoing Clinical Trials: • Sunitinib either before or after cytoreductive nephrectomy: A phase II trial in patients with metastatic renal cell carcinoma. • Multicenter, phase II evaluation of torisel as II-line treatment for metastatic RCC in patients progressing after cytokine therapy, tyrosine kinase, or angiogenesis inhibitors. • A Study of Pazopanib versus Sunitinib in the Treatment of Subjects with Locally Advanced and/or Metastatic Renal Cell Carcinoma. • “Retry”study - phase II study of Sunitinib as rechallenge third-line therapy in metastatic renal cancer. Bladder Cancer Ongoing Clinical Trials • Randomized phase II study assessing the combination of Vinflunine with Gemcitabine and Vinflunine with Carboplatin in patients ineligible to cisplatin with advanced or metastatic transitional cell carcinoma of the urothelium. • Selective Bladder Preservation Therapy for Patients with Muscle-Invasive Bladder Cancer and who are candidate to Cystectomy.
Head and Neck Cancer • Long term responders to first line chemotherapy plus cetuximab in recurrent/metastatic Head and Neck cancer: a genomic landscape approach to identify predictive biomarkers. • Evaluation of feasibility and efficacy of alternative schedules in patients treated with cetuximab + platinum based therapy for recurrent/metastatic squamous cell carcinoma of Head and Neck. • Collaboration to define national and shared guidelines in the management of main toxicity due to chemoradiation therapies Neoadjuvant docetaxel, cisplatin and 5- fluorouracil (TPF) followed by radiotherapy plus concomitant chemotherapy or cetuximab versus radiotherapy plus concomitant chemotherapy or cetuximab in patients with locally advanced squamous cell carcinoma of the Head & Neck. • A Multicenter, Randomized, Double-Blind, PlaceboControlled, Phase 3 Trial of E7080 in 131I-Refractory Differentiated Thyroid Cancer. • A Randomised, Double-Blind, Placebo-Controlled, Multi-center, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects with Resected Squamous cell carcinoma of the Head & Neck. • A randomised, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemo-radiotherapy in primary unresected patients with stage III, IVa, or IVb loco-regionally advanced Head and Neck squamous cell carcinoma.
IEO — Scientific Report 2012 — Ongoing Research 2013
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