Posts Tagged ‘androgen independent prostate cancer’

Abiraterone (Zytiga) Approved for Metastatic Hormone-Resistant Prostate Cancer

May 4, 2011

The FDA approved abiraterone (Zytiga) for treatment of castrate-resistant (androgen-independent) metastatic prostate cancer for patients who have received prior chemotherapy containing docetaxel (Taxotere).  The approval was based on an interim analysis of overall survival (OS) in a placebo-controlled randomized trial, each arm receiving prednisone at 5 mg 2x/day orally.  The median OS was 14.8 months in the abiraterone/prednisone group, compared to 10.9 months in the placebo/prednisone group (p<0.0001). 

The most common adverse reactions (>5%) were joint swelling or discomfort, low potassium, edema, muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, dyspepsia, nocturia, and upper respiratory tract infection.  Abnormal liver function tests were seen in <1% of patients. 

Abiraterone blood levels were substantially higher when the drug was taken with food (compared to a fasting state).  The recommended dose and schedule for abiraterone is 1000 mg orally once/day, in combination with prednisone 5 mg orally 2x/day.  Abiraterone should be taken on an empty stomach.  No food should be consumed for at least two hours before the dose and for at least one hour after the dose.

XRP6258 (Cabazitaxel) Increased Survival for Patients with Advanced Hormone Refractory Prostate Cancer

March 10, 2010

Data from the TROPIC clinical trial was announced at the American Society of Clinical Oncology (ASCO) 2010 Genitourinary Cancer Symposium. This phase III study was conducted at 146 sites in 26 countries. CORT was the study site in Dallas, TX. The study included 755 men patients with hormone refractory prostate cancer whose disease had progressed despite previous docetaxel (Taxotere) chemotherapy.

The primary endpoint of the study was overall survival. Patients were randomly assigned to receive XRP6258 (Cabazitaxel) plus prednisone/prednisolone or mitoxantrone plus prednisone/prednisolone, the latter being an existing stardard-of-care therapy for second-line chemotherapy in such patients.

The results showed that the combination of cabazitaxel plus prednisone/prednisolone signficantly reduced the risk of death by 30% (hazard ratio (HR)=0.70; CI: 0.59-0.83; p<0.0001) with a clinically meaningful improvement in median overall survival of 15.1 months in the cabazitaxel combination arm versus 12.7 months in the mitoxantrone combination arm.

CORT wishes to thank the patients who participated in this clinical trial. Their courage and generosity of spirit enabled such critical reseach to be done.

Based on important clinical trial information such as was obtained in this study, cabazitaxel recently received fast track designation from the US FDA.

Satraplatin Fails to Improve Survival in Hormone Refractory Prostate Cancer

November 17, 2007

Satraplatin, a novel oral platinum compound under development, failed to improve overall survival in late-stage, pre-treated hormone refractory prostate cancer (HRPC).  Early evaluations of satraplatin in HRPC in the SPARC (Satraplatin and Prednisone Against Refractory Cancer) trial looked promising, but the final survival analysis did not show statistical improvement, and the Expanded Access Study Program has been closed to further accrual. 

The explanation of this finding is not yet known.  Investigators who had experience with Satraplatin were surprised, given the apparent activity that had been seen in some patients treated.   A careful analysis of the patients who responded may yield insight into what clinical or molecular/genetic determinants led to improvements in individual cases, which may lead to insights into how future trials with Satraplatin may be better designed to enrich the population of patients who are more likely to benefit from Satraplatin.

ASCENT-2 Novacea Study Halted

November 7, 2007

Novacea, Inc. (NASDAQ: NOVC) announced on 11/5/07 that the company has ended its Phase 3 ASCENT-2 clinical trial of Asentar(TM) (DN-101), the company’s lead investigational cancer therapy for the treatment of patients with androgen-independent prostate cancer, or AIPC, due to an imbalance of deaths between the two treatment arms, as observed by the Data Safety Monitoring Board (DSMB) for the clinical study.


The company and its partner, Schering-Plough, plan to fully analyze the clinical data to attempt to understand the cause of the higher death rate in the Asentar plus Taxotere(R) (docetaxel) treatment group. The study was comparing the benefits of weekly Asentar plus Taxotere to the current standard of care in the treatment of AIPC. To date, more than 900 of the planned total of 1,200 patients were enrolled in this study at multiple centers in various countries, including the United States, Canada, Germany, and Central Europe.
“The safety of the patients in our trials is our top concern. As such, Novacea and Schering-Plough have decided to end the ASCENT-2 trial, however, the product development alliance will continue,” said John P. Walker, chief executive officer of Novacea. “The findings in ASCENT-2 are extremely surprising and disappointing to us, given the promising clinical activity that we observed in our Phase 2 ASCENT trial. Importantly, preliminary analysis has not identified any unexpected safety findings with Asentar. Over the next few months, we plan to further analyze the data, and discuss the findings with ASCENT-2 principal investigators and with prostate cancer experts to attempt to determine the possible causes for this outcome. We have informed all relevant constituents, most importantly the clinical trial sites treating patients and the regulatory authorities, and have suspended enrollment in other ongoing or planned trials in other indications until we have had a chance to assess the data more completely,” said Mr. Walker.

Combination Chemotherapy for Hormone-Refractory Prostate Cancer Failing Initial Therapies

September 29, 2007

The regimens of ketoconazole, doxorubicin (Adriamycin), vinblastine (Velban), and estramustine (KAVE) or estramustine and vinblastine (EV) are active in patients with hormone refractory prostate cancer (HRPC) who have progressed following docetaxel (Taxotere) chemotherapy. CORT is participating in the multicenter MDA-3410 study, which tests the KAVE therapy or the EV regimen, followed by weekly doxorubicin for six weeks in HRPC. Patients who complete therapy are then randomly assigned to therapy with a radioactive isotope, Strontium-89 (Sr-89, which is FDA-approved for treatment of metastatic prostate cancer). The goal of the study is to measure the response rate, remission duration, and tolerance of patients to this treatment.

Risks of these treatments include hair loss, fatigue, nausea, vomiting, diarrhea, thrombosis, low blood counts, fever, sensory neuropathy, deficiency of adrenal hormones, and cardiac dysfunction.

For more information on our research studies, visit www.CORTPA.com, or speak with a Study Coordinator at 972-566-5588.

Satraplatin for Hormone Refractory Prostate Cancer

September 28, 2007

Satraplatin is a platinum chemotherapy compound that can be administered orally. It appears to have minimal risk of neuropathy or kidney injury. Phase III studies have demonstrated that Satraplatin is more active that prednisone alone for patients with advanced HRPC who have already failed existing standard therapies. Satraplatin is pending approval by the FDA. It is currently available only within a study program. CORT is pleased to offer access to Satraplatin through the Expanded Access Study. All patients who qualify will receive Satraplatin. The risks of Satraplatin include nausea, vomiting, fatigue, diarrhea, and low blood counts.

For more information on our research studies, visit www.CORTPA.com, or speak with a Study Coordinator at 972-566-5588.

XRP6258 for Hormone-Refractory Prostate Cancer

September 28, 2007

XRP6258 is a novel taxane that has been shown to be active in patients with hormone refractory prostate cancer (HRPC) who have failed or progressed after prior therapy with docetaxel (Taxotere) and prednisone, the standard first-line treatment for HRPC. CORT is conducting a study of XRP6258 plus prednisone versus standard mitoxantrone (Novantrone) and prednisone in HRPC patients who have failed prior Taxotere therapy.

The risks of XRP6258 are sensory neuropathy, fatigue, nausea, vomiting, low blood counts, fever, infection, allergic reaction, or hair loss. The risks of standard mitoxantrone therapy are fatigue, hair loss, low blood counts, fever, infection, mouth ulcers, or cardiac dysfunction.

For more information on our research studies, visit www.CORTPA.com, or speak with a Study Coordinator at 972-566-5588.

DN-101 (Ascentar) for Hormone-Refractory Prostate Cancer

September 28, 2007

DN-101 (Ascentar) is a high-dose formulation of the active form of vitamin D. Vitamin D, once thought of as only a hormone that regulates calcium metabolism, is now known to be an important growth regulator in many types of tissues, by its action on vitamin D receptors. Activation of vitamin D receptors slows or stops cell division, and promotes differentiation of cells, the process of cells taking on normal functions. In an initial phase II study, addition of DN-101 to standard chemotherapy with docetaxel (Taxotere) and prednisone has been shown to increase response to treatment and prolong disease control in patients with hormone-refractory prostate cancer (HRPC). CORT is conducting a phase III study of standard Taxotere and prednisone therapy with or without Ascentar for the first-line treatment of HRPC. All patients do receive standard therapy.  

The risks of chemotherapy for HRPC in this study are fatigue, nausea, vomiting, muscle or bone aches, sensory neuropathy, fever, allergic reaction, or low blood counts. These risks are those of standard treatment. The risk of G-VAX is injection site swelling and discomfort.

For more information on our research studies, visit www.CORTPA.com, or speak with a Study Coordinator at 972-566-5588.

G-VAX Vaccine Study for Hormone-Refractory Prostate Cancer

September 28, 2007

G-VAX is a cellular vaccine against prostate cancer. Initial studies have demonstrated activity of G-VAX in prostate cancer patients who have failed hormone treatments (hormone refractory prostate cancer, HRPC). Two national studies of G-VAX for HRPC have been conducted at CORT. The first, VITAL-1, is no longer enrolling patients. This study tested the G-VAX therapy against standard therapy with docetaxel (Taxotere) and prednisone in patients who do not have bone pain related to metastatic disease. The second study, VITAL-2, is continuing at CORT, enrolling patients who have active bone pain related to their metastatic disease. This study tests standard therapy with Taxotere and prednisone with or without the G-VAX vaccine. All patients do receive standard therapy.

The risks of chemotherapy for HRPC in this study are fatigue, nausea, vomiting, muscle or bone aches, sensory neuropathy, fever, allergic reaction, or low blood counts. These risks are those of standard treatment. The risk of G-VAX is injection site swelling and discomfort. For more information on our research studies, visit www.CORTPA.com, or speak with a Study Coordinator at 972-566-5588.