Archive for September, 2007

DTIC (Dacarbazine) and IMCL-1121B for First-Line Treatment of Metastatic Melanoma

September 29, 2007

DTIC (Dacarbazine) chemotherapy is the most active approved chemotherapy agent for treatment of metastatic melanoma. Responses are infrequent, and generally of short duration. The risks of Dacarbazine are hair loss, nausea, vomiting, and low blood counts.

Anti-angiogenic drugs that block tumor blood vessel formation have shown promise in treatment of melanoma. IMCL-1121B is a fully-human monoclonal antibody that blocks the vascular endothelial growth factor receptor (VEGF-R2). The risks of IMCL-1121B are similar to other, approved anti-VEGF treatments: infusion reaction, proteinuria (protein in the urine), delayed wound healing, bleeding, thrombosis, hypertension, and rare bowel perforation.

CORT is conducting a phase II study of Dacarbazine and IMCL-1121B in the first-line treatment of metastatic melanoma. All patients who participate will receive both drugs.  The study will determine if the addition of IMCL-1121B to Dacarbazine therapy improves the response rate and delays progression of the disease.

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

MDX-010 (Ipilimumab), a CTLA-4 Inhibitor: Second-Line Treatment of Metastatic Melanoma

September 29, 2007

Immunotherapies that enhance anti-cancer immune responses against melanoma have shown infrequent, but occasionally durable (long-lasting) remissions of metastatic melanoma. Treatment with high-dose interleukin-2 (IL-2) is an example of such therapy. Treatment toxicities of high-dose IL-2 are very high, and potentially fatal. Patients who are older, with renal, pulmonary, or cardiac disease cannot usually be treated with such therapy.

Other immune therapies are in testing for the treatment of metastatic melanoma. MDX-010 (Ipilimumab) is an inhibitor of CTLA-4. CTLA-4 suppresses T-cell lymphocyte function, inhibiting anti-tumor immunity. By blocking CTLA-4, ipilimumab enhances T-cell anti-tumor immunity. Phase I and II studies have demonstrated that ipilimumab has activity in metastatic melanoma. Some responses have been durable. These studies have demonstrated that response to ipilimumab is related to HLA-A2 status (a protein marker on human lymphocyte white blood cells).

CORT is participating in a multicenter study of ipilimumab for the second-line treatment of metastatic melanoma. Patients who qualify and who are HLA-A2 positive are randomly assigned to one of three dose levels of ipilimumab treatment.

The risks of ipilimumab are fever, rash, diarrhea, bowel inflammation (which may be severe), infusion reaction, loss of pituitary hormone function, and hypothyroidism.

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

Chemotherapy and Sorafenib (Nexavar) for First-Line Treatment of Metastatic Melanoma

September 29, 2007

The combination of carboplatin (Paraplatin) and paclitaxel (Taxol) is active in metastatic melanoma. This combination of drugs is not approved for melanoma treatment, but is approved and commonly utilized in treatment of lung and other cancers. Treatment with Paraplatin and Taxol has manageable risks, which include fatigue, hair loss, nausea, vomiting, low blood counts, fever, infection, sensory neuropathy, and allergic reactions.

Sorafenib (Nexavar) is an oral drug that targets several specific growth promoting proteins in cancer cells. It inhibits b-raf (increased in melanoma cells) and it blocks angiogenesis (blood vessel formation). It is FDA-approved in the treatment of metastatic renal (kidney) cancer. The risks of Nexavar include fatigue, nausea, vomiting, diarrhea, rash, proteinuria (protein in the urine), increased blood pressure, low thyroid function, low blood counts, delayed wound healing, bleeding and thrombosis.

CORT is testing the combination of Paraplatin and Taxol with or without Nexavar in the first-line treatment of metastatic melanoma.

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

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.

Sunitinib (Sutent) for Metastatic Renal (Kidney) Cancer

September 28, 2007

Recent studies of sunitinib (Sutent) in patients with metastatic renal cell carcinoma have demonstrated it is effective in prolonging disease control and survival. The FDA-approved dosing regimen for Sutent is 50 mg per day orally for four weeks, followed by a 2-week rest period off of medication (the 4/2 regimen). CORT is conducting a study comparing a continuous dosing regimen of Sutent (37.5 mg per day orally, without treatment interruption) compared to standard dosing with the 4/2 regimen. The study will determine which regimen has superior outcomes and which has the least toxicity (side effects).

The risks of treatment on this study are fatigue, anemia, nausea, vomiting, diarrhea, proteinuria (protein in the urine), delayed wound healing, bleeding, or thrombosis.

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

Post-Operative (Adjuvant) Therapy for Completely Resected Renal (Kidney) Cancer

September 28, 2007

After complete surgical resection of localized renal cell carcinoma, there is no existing standard post-operative therapy that is known to prevent or delay the occurrence of metastatic disease. Recent studies of sunitinib (Sutent) and sorafenib (Nexavar) in patients with metastatic renal cell carcinoma have demonstrated that both drugs are effective in prolonging disease control and survival. Based on these encouraging results, CORT is participating in the national study (ECOG 2805) for adjuvant treatment of resected, non-metastatic renal cell carcinoma. Patients who have complete resection of their renal tumors are eligible. Patients will be randomly assigned to either placebo therapy, treatment with Sutent, or treatment with Nexavar. Duration of treatment is approximately one year. Both drugs are orally administered. 

The risks of treatment on this study are fatigue, anemia, nausea, vomiting, diarrhea, proteinuria (protein in the urine), delayed wound healing, bleeding, or thrombosis.

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.