Phase II, randomized, placebo-controlled trial of neoadjuvant celecoxib in men with clinically localized prostate cancer: evaluation of drug-specific biomarkers.

Purpose: Cyclooxygenase-2 (COX-2) is a potential pharmacologic target for the prevention of various malignancies, including prostate cancer. We conducted a randomized, double-blind trial to examine the effect of celecoxib on drug-specific biomarkers from prostate tissue obtained at prostatectomy.

Patients And Methods: Patients with localized prostate cancer and Gleason sum > or = 7, prostate-specific antigen (PSA) > or = 15 ng/mL, clinical stage T2b or greater, or any combination with greater than 45% risk of capsular penetration were randomly assigned to celecoxib 400 mg by mouth twice daily or placebo for 4 to 6 weeks before prostatectomy.

Prostate cancer: a practical approach to current management of recurrent disease.

Prostate cancer is the leading cause of cancer in men in the United States, with 234,460 men expected to be diagnosed as having the disease in 2006 (33% of cancers in men), and the third leading cause of cancer deaths in men, with 27,350 men expected to die of the disease (9% of cancer deaths). Through early detection and improved local therapies, including surgery or radiation therapy, a large number of men will be cured, but unfortunately, a significant number of men will still experience relapse of disease and require continued surveillance and ongoing therapy. This article discusses approaches to treatment of men who have recurrent disease, including active surveillance, androgen ablation therapy, secondary hormone therapy, chemotherapy, bisphosphonates, radiation therapy, and future directions.

Psychometric evaluation of two scales assessing functional status and peripheral neuropathy associated with chemotherapy for ovarian cancer: a gynecologic oncology group study.

Purpose/objectives: To evaluate the psychometric properties of two adapted scales, one for functional status and one for peripheral neuropathy secondary to neurotoxic chemotherapy.

Design: Repeated measures methodologic design conducted within a Gynecologic Oncology Group (GOG) phase III clinical trial that randomly assigned patients with advanced epithelial ovarian cancer to cisplatin and cyclophosphamide or cisplatin and paclitaxel.

Setting: 8 GOG institutions participating in the GOG clinical trial.

A phase II trial of temozolomide and IFN-alpha in patients with advanced renal cell carcinoma.

The combination of temozolomide (TEM) and interferon-alpha (IFN-alpha) previously demonstrated a 30% response rate in metastatic melanoma. A single institution, phase II trial evaluating the efficacy of TEM/IFN in patients with advanced renal cell carcinoma (RCC) was conducted. Safety and tumor response were the main outcomes.

Phase 3 randomized trial evaluating second-line hormonal therapy versus docetaxel-estramustine combination chemotherapy on progression-free survival in asymptomatic patients with a rising prostate-specific antigen level after hormonal therapy for prostate cancer: an Eastern Cooperative Oncology Group (E1899), Intergroup/Clinical Trials Support Unit study.

Despite improvements in early detection of prostate cancer when it is clinically localized--and therefore most amenable to curative local therapies-- approximately 33% of men with early prostate cancer will develop biochemical failure with a rising prostate-specific antigen (PSA) during follow-up. The early use of androgen suppression in this group of men has changed the clinical picture of androgen-independent disease. Now, there are men on androgen suppression who will develop biochemical failure and remain free of clinical or radiographic evidence of metastatic disease for a period of time.

Pharmacological treatments for prostate cancer.

Recently, chemotherapy for prostate cancer has been primarily reserved for the palliation of symptoms secondary to prostate cancer. Chemotherapy regimens and new approaches are being developed that offer new hope of response and improved survival to men with prostate cancer. This paper discusses pharmacological strategies that are under investigation: cytotoxic agents and biological or targeted therapies, including the microtubule inhibitors (taxane/taxoids, vinorelbine) alone and in novel combinations with other experimental agents such calcitriol, thalidomide or flavopiridol (cell-cycle inhibitor) and treatment with epothilone analogues; endothelin receptor antagonists; other novel strategies such as vaccine therapy (GVAX; Cell Genesys) and prostate-specific membrane antibodies; and bisphosphonates.