Posts Tagged ‘Dallas’

New Treatment for Her-2+ Metastatic Breast Cancer Opens at CORT

September 4, 2009

CORT has opened the Wyeth 3144A2 3005 WW Study testing the oral her-2 inhibitor, neratinib, in combination with paclitaxel (Taxol), versus standard therapy with trastuzumab (Herceptin) in combination with paclitaxel, for first-line treatment of her-2+ metastatic breast cancer. 

Neratinib is an oral anti-her-1/her-2 drug with demonstrated efficacy in metastatic her-2 positive breast cancer.  The safety studies have demonstrated acceptable and manageable toxicity of neratinib, including rash and occasional loose stools or diarrhea being most common.  As with other her-2 inhibiting drugs, neratinib may lower the cardiac ejection fraction, so serial monitoring of cardiac function is routine.  The Phase III study will compare the efficacy and tolerability of paclitaxel with either oral neratinib or trastuzumab (a monoclonal antibody against her-2 protein, given IV).

The potential advantages of neratinib include improved convenience (and possibly improved safety).  The drug is given orally.  

For more information about this study, visit our website at www.CORTPA.com, or contact a Research Coordinator at 972-566-5588.  

Patients with her-2+ breast cancer may also be eligible for other studies and treatment at CORT, including non-study therapy.  The principle investigator at CORT is Dr. Barry Mirtsching.  He has personally conducted over 200 trials in cancer therapy over 16 years, many in breast cancer management.  Experience in both trial and non-trial breast cancer management benefits patients by producing better treatment outcomes.  Care at CORT is individual and personal, with adequate time for problem-solving and direct contact with the physician.

STRIDE Breast Cancer Study Testing Stimuvax Cancer Vaccine Open at CORT

September 4, 2009

CORT has opened the STRIDE study for first-line treatment of metastatic, hormone-receptor positive breast cancer.  The study will test standard anti-estrogen therapy in combination with a vaccine placebo, versus standard anti-estrogen therapy with the Stimuvax cancer vaccine.  The press release regarding this study is posted below.

For more information about this study, or to schedule appointments for evaluation and treatment of metastatic breast cancer, visit the CORT website at www.CORTPA.com, or call 972-566-5588 and ask to speak with a Patient Care Coordinator or CORT Research Nurse. 

STRIDE Press Announcement:

24 Jun 2009 – Merck KGaA announced the initiation of its global Phase III clinical study of the therapeutic cancer vaccine Stimuvax® (BLP25 liposome vaccine, L-BLP25) in patients with advanced, inoperable breast cancer. The STRIDEa study will determine if Stimuvax can extend progression-free survival in patients treated with hormonal therapy who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer. Overall survival, quality of life, tumor response and safety will also be assessed in this study. The STRIDE study will be supervised by an expert Steering Committee and is sponsored by Merck, which is leading the development of Stimuvax.
STRIDE will enroll more than 900 patients with advanced breast cancer at an estimated 180 sites in over 30 countries – within North America, Europe, Asia and Australia; the Principal Investigator is Dr Lawrence Shulman, Chief Medical Officer and Senior Vice President for Medical Affairs, Dana-Farber Cancer Institute, Boston, USA.
 
Stimuvax is an investigational therapeutic cancer vaccine designed to stimulate the body’s immune system to identify and target cancer cells that express MUC1, an antigen commonly expressed in breast cancer as well as in other common cancer types such as non-small cell lung cancer (NSCLC), multiple myeloma, and colorectal, prostate and ovarian cancers.
 
The Phase III program for Stimuvax was initiated following results from a randomized Phase IIb study of 171 patients with inoperable stage IIIb NSCLC, in which Stimuvax showed a trend towards extending median overall survival from 13.3 months for patients receiving best supportive care (BSC) to 30.6 months for patients receiving Stimuvax plus BSC. Reported side effects included mild-to-moderate flu-like symptoms, gastrointestinal disturbances and mild injection-site reactions. A further long-term safety analysis in 16 patients receiving prolonged treatment with Stimuvax from 2 to 8.2 years showed the most common treatment-related adverse events were injection-site reactions (ISRs) with no evidence of autoimmune reactions. These data also show that the occurrence of ISRs decreased with long-term therapy (>1 year).

Proleukin (Interleukin-2) Therapy for Renal Cell Carcinoma: Treatment Option for Select Patients

August 6, 2009

Therapy options for patients with metastatic renal cell carcinoma has expanded significantly, with the FDA approval of sunitinib (Sutent), sorafenib (Nexavar), everolimus (Affinitor), temsirolimus (Torisel), and bevacizumab (Avastin).  These drugs have significant anti-tumor and anti-angiogenic effects.  Progression-free survival (PFS) is improved when compared to placebo or alpha-interferon (Intron-A) therapy.  Many patients will respond to more than one of these agents, and therefore overall outcomes for patients receiving sequential treatments may be improved.   These therapies have expected and manageable toxicities and risks, and are delivered on an outpatient basis.  Nonetheless, these new therapies do not offer curative potential to any patient when used in patients with established metastatic disease.   Patients with reduced overall health and function (performance status) can be treated with these agents.

Interleukin-2 (IL-2, Proleukin) is an FDA approved therapy for metastatic renal cancer.   It is a potent immune stimulator, and it may have anti-angiogenic activity.  Since its clinical development nearly two decades ago, it remains the only therapy with a known curative potential for patients with metastatic renal carcinoma.  Treatment with IL-2 has substantial toxicity, priniciply secondary to capillary leak syndrome and vasodilation, which can result in serious hypotension, fluid accumulation, edema, pulmonary congestion, renal dysfunction, or other organ failure.  Patient selection for this form of therapy is critical.  Only patients with good performance status and adequate kidney, heart, and lung function are potential candidates for IL-2 treatment.  Treatment is delivered on an inpatient basis, under carefully-monitored circumstances, usually in the intensive care unit.  Treatment is delivered by a specialized team of oncologists and nurses, who are familiar with the specific program of IL-2 therapy, and have experience in management and prevention of toxicities.   A critical care physician (ICU physician) is also engaged in management.  Therapy lasts for 5 days, with several additional days potentially required for resolution of treatment-related lab or clinical changes.  Most of the treatment-related side effects abate rapidly after the therapy is completed.  A second cycle of inpatient IL-2 therapy is given after the patient has had a brief period of outpatient recovery.   In studies of IL-2 in metastatic kidney cancer, the overall response rate (out of 255 patients) = 15% (7% complete, 8% partial). That is not higher than other recently-approved medications.  However, the median duration of complete response (CR*) is 6.7+ years (range 7 months – 10+ years).  Those long-term results are not achieved by other treatments for metastatic renal cancer.

Additional information about IL-2 therapy is available at www.Proleukin.com.  CORT is a provider for IL-2 therapy in the North Texas area.  Our patients are treated in Medical City Dallas Hospital.

For information about CORT, or to schedule a consultation about treatment of renal cancer, call 972-566-5588 to speak with a Patient Care Coordinator.  Additional information about CORT and directions are available at www.CORTPA.com.

CORT Clinical Trials Brochure: PDF Version

December 20, 2008

CORT offers a broad array of oncology clinical phase II-III studies for solid tumors and lymphomas.  The attached PDF lists our current or pending studies. For more information about our studies, visit the CORT website at www.CORTPA.com, or contact a Reseach Coordinator at 972-566-5588. 

CORT Clinical Trials March 2010