Posts Tagged ‘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.

Prostate Cancer Immunotherapy Study Open at CORT

August 5, 2009

CORT is actively enrolling patients with metastatic hormone-refractory (androgen-independent) prostate cancer in the BMS 184-043 study of ipilimumab (versus placebo).   The study is open to patients who have at least one bone metastasis, and who have progressed after prior therapy with docetaxel (Taxotere).  Other inclusions and exclusions are required.   Ipilimumab is a monoclonal antibody that inhibits the cellular function of CTLA-4.  CTLA-4 inhibits the T-cell immune response to cancer cells, and by blocking this molecule, T-cells are activated.  Ipilimumab is in clinical development in melanoma (also at CORT).  Responses in both metastatic prostate cancer and melanoma have been demonstrated.  The drug is given every 3 weeks IV for four treatments (induction).  Thereafter, for patients with improvement or stability in their disease, the drug is continued every 3 months (maintenance).  The most common risks are rash and diarrhea.  Other risks include changes in pituitary, thyroid, and adrenal function.  Rare auto-immune reactions (some severe and potentially life-threatening) have occurred.

CORT enrolled the first US patient to the prostate cancer study in 6/09. 

To learn more about this study, or to schedule consultation regard this and other treatments for prostate cancer, call 972-566-5588.   Additional information, including directions to the office are located at www.CORTPA.com.

C90202 Study: Reducing of Skeletal Morbidity in Metastatic Prostate Cancer

December 10, 2008

Prostate cancer most commonly spreads to bone, primarily in the spine and pelvis.  Patients most often present with a rising PSA (prostate specific antigen) serum level, bone discomfort, weight loss, fatigue, or anemia, depending on the extent of disease.  Some patients may even be asymptomatic at the time that metastatic disease is first determined, for example after a rising PSA is noted and a bone scan is obtained.  Most patients have not had therapy other than local treatment (surgery or RT), although some have had hormonal therapy along with their initial local therapy.  When metastatic prostate cancer is diagnosed, first-line treatment should consist of hormone suppression with LHRH therapy (or orchiectomy, not commonly employed now) to lower the testosterone level.  The addition of anti-androgen drug therapy (e.g., flutamide, biclutamide, or nilandron) to LHRH therapy may also be considered.  Such therapy often will cause disease regression in such “hormone sensitive” or “androgen dependent” metastatic prostate cancer, wtih control of the disease and reduction of the PSA.  Chemotherapy is not considered part of  standard managment during the hormone sensitive phase of metastatic disease, except as part of a research study,  such as the E3805 Study (open at CORT), which tests hormonal therapy with or without doctaxel (Taxotere) chemotherapy in patients with extensive, newly diagnosed metastatic hormone sensitive disease.  Doectaxel is a standard, FDA-approved therapy for treatment of prostate cancer that has become resistant to hormonal therapy.  The E3805 study will determine if the early use of chemotherapy will improve the outcome in patients with metastatic prostate cancer. 

The CALGB Study C90202 for newly diagnosed metastatic hormone-sensitive prostate cancer patients is now open at CORT. This study tests a potent bisphosphonate drug, zoledronic acid (Zometa), compared to placebo therapy, in combination with standard hormonal therapy for patients with metastatic disease, as defined by having at least one bone metastasis on standard imaging.   These patients may have hormone sensitive disease that is less extensive than that which is required in the E3805 study.  

Zoledronic acid is an FDA-approved treatment for patients with bone metastases.  It is most commonly employed in patients with multiple boney lesions who have symptoms.  It is known to reduce bone fractures and pain, events which result in significant morbidity (or mortality) for patients.   Freequently, the use of zoledronic acid is delayed until widespread disease is present,  such as when the disease is becoming resistant to hormonal therapy.  Whether or not the early application of zoledronic acid therapy helps to slow the progression of disease is not known.  The aim of the C90202 study is to de3termine if zoledronic acid reduces bone-related fracture or events in patients with minimal volume of metastatic prostate cancer that is still hormone sensitive. 

Excitement about the use of bisphosphonate drug therapy in cancer treatmetn has excalated, given the provacative findings of the ABCSG Trial 12 study in early breast cancer, which showed that the recurrence rate in these women was reduced by 35%, when zoledronic acid was added to hormonal therapy.  This study found that zoledronic acid (compared to placebo therapy) reduced recurrence of breast cancer not only in bone, but at other sites.  The findings suggest that zoledronic acid has anti-tumor properties that are independent of its effects in bone.  Such a finding may not be limited to patients with breast cancer.  Therefore, a secondary aim of the C90202 study is to determine the overall and progression-free survival impact of zoledronic acid therapy. 

For more information about these studies in hormone sensitive metastatic prostate cancer, contact a CORT Research Coordinator at 972-566-5588, or visit our website at www.CORTPA.com.

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.

Combining Chemotherapy with Initial Hormone Therapy for Metastatic Prostate Cancer

September 29, 2007

Androgen ablation hormonal therapy (castration or LHRH drugs to reduce androgen levels) are the standard initial management for metastatic prostate cancer patients, as most have hormonally sensitive disease. Patients with high risk features (more extensive boney metastatic disease, high Gleason histologic scores) might benefit from the initial addition of chemotherapy to hormonal treatment.

CORT is participating in the national ECOG 3805 study called the CHAARTED (ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease), which moves docetaxel (Taxotere) chemotherapy earlier into the hormone-sensitive phase of metastatic prostate cancer treatment. Patients with poorer risk, higher PSA levels and higher alkaline phosphatase (bone enzyme) levels with bone pain are randomly assigned to treatment with hormones versus hormones with Taxotere chemotherapy. The goal of the study is to determine if the addition of docetaxel to standard androgen ablation therapy improves remission duration and survival, when compared to androgen deprivation therapy alone.

The side effects most frequently experienced with Taxotere include fatigue, nausea, vomiting, diarrhea, fever, infection, sensory neuropathy, low blood counts, and fever. Standard androgen ablation hormonal therapy may produce fatigue, hot flashes, impotence, increased risk of thrombosis, or loss of libido.

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.