Archive for November, 2007

Neoadjuvant Breast Cancer Chemotherapy NSABP B-40 Study Open at CORT

November 17, 2007

The NSABP (National Surgical Adjuvant Breast Project) B-40 Study of new drug combinations, sequence, and the addition of anti-angiogenic therapy (bevacizumab=Avastin) for the pre-operative (neoadjuvant) treatment of localized breast cancer continues at the Center for Oncology Research & Treatment (CORT) in Dallas, Texas.   Pre-operative chemotherapy for localized breast cancer is an established approach to therapy.  Reduction in tumor size may increase the proportion of breast cancer patients who are candidates for breast conservation surgery (lumpectomy).  Pre-operative therapy also may give important insight into what drug therapy benefits the patient individually, an observation that is not possible when chemotherapy is given after surgical excision of the breast cancer. 

An established sequence of pre-operative chemotherapy utilizes doxorubicin (Adriamycin, and anthracycline drug) and cyclophosphamide (Cytoxan) followed by docetaxel (Taxotere) therapy (AC>T>surgery).  Recently, improved response and survival in metastatic breast cancer has been demonstrated with the combinations of gemcitabine (Gemzar) and a taxane drug (GT) or capecitabine (Xeloda) and a taxane drug (XT), when compared to taxane therapy alone.  Avastin (a monoclonal antibody against vascular endothelial growth factor, anti-VEGF) has been shown to improve the progression-free survival in metastatic breast cancer when added to standard taxane therapy.  Based upon these promising findings, the integration of Gemzar and Xeloda and Avastin into both adjuvant and neoadjuvant treatment studies has begun. 

In NSABP B-40, a NCI-sponsored cooperative research group study, the neoadjuvant pre-operative treatment of GT>AC or XT>AC are compared to standard T>AC.  In this study, drugs are given in a “dose dense” fashion, every 2 weeks.  Patients in all three pre-operative chemotherapy treatment arms will randomly be assigned to the addition of Avastin or placebo in addition to the chemotherapy. 

Pre-treatment biopsy specimens need to be collected on this study for analysis.  Therefore, potentially eligible patients should seek consultation with a NSABP B-40 medical oncologist prior to their initial biospies, so enrollment to the study can be done before the biopsy is done.   Patients who have tumors >2 cm are eligible.  CORT study personnel will work with your surgeon quickly after consultation, consent, and enrollment, so that your biopsy can be done properly to ensure eligibilty for the study.  Biopsies done prior to enrollment are not suitable and disqualify patients from participation. 

 For more information about this study, contact a Research Coordinator at 972-566-5588 (Dallas) or 972-981-4012 (Plano), or visit our website at www.CORTPA.com.   Dr. Barry Mirtsching or CORT is the Principle Investigator for this study.

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.