1. A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs as and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer
2. A Multicenter, Randomized, DOuble-Blind Study Comparing the Efficacy and Safety of Aflibercept versus Placebo Administered Every 3 Weeks in patients Treated with Docetaxel/Prednisone for Metastatic Androgen-Independent Prostate Cancer
3. Phase II Study of a Weekly Schedule of BMS-247550 for Patients with Hormone Refractory Prostate Cancer

A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs as and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer

Eligibility Criteria (per Protocol Amendment 4, dated 05/15/08):

1. Clinically negative lymph nodes, as established by imaging (pelvic CT or pelvic MR), nodal sampling, or dissection within 90 days prior to registration.
2. Zubrod Performance Status of 0-1.
3. Medical oncology consultation prior to registration.
4. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is within 50 days prior to the date of registration.
5. Not eligible if PSA is greater than 150.
6. Not eligible if there is evidence of M1 metastatic disease.
7. Not eligible if there are pathologically positive lymph nodes or nodes greater than 1.5 cm on imaging.
8. Not eligible if there has been prior systemic chemotherapy for prostate cancer (however, prior chemotherapy for a different type of cancer is allowed).
9. Not eligible if there has been a transmural myocardial infarction (heart attack) within the 6 months prior to registration.
10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

A Multicenter, Randomized, DOuble-Blind Study Comparing the Efficacy and Safety of Aflibercept versus Placebo Administered Every 3 Weeks in patients Treated with Docetaxel/Prednisone for Metastatic Androgen-Independent Prostate Cancer

Eligibility Criteria (per protocol dated 04/07/08):

1. Histologically- or cytologically-confirmed prostate adenocarcinoma.
2. Subject will be eligible if he has metastatic disease.
3. Progressive disease while receiving hormonal therapy or after surgical castration and documented as per protocol guidelines.
4. Effective castration (serum testosterone levels of no more that 50 ng/dL) by orchiectomy and/or LHRH agonists with or without anti-androgens. If subject has been treated with LHRH agonists (i.e., without orchiectomy), then this therapy should be continued. If subject was either started on complete androgen blockade, or had a PSA response (defined by any reduction in PSA sustained for at least 3 months) after adding an antiandrogen, prior antiandrogen therapy should be stopped before randomization: at least 6 weeks for bicalutamide and nilutamide, and at least 4 weeks for flutamide, megestrol acetate and any other hormonal therapy.
5. Subject is not eligible if there is prior cytotoxic chemotherapy for prostate cancer (except adjuvant/neoadjuvant treatment completed more than 3 years ago).
6. Not eligible if there have been less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. Subject may be on bisphosphonates prior to study entry.
7. Subject not eligible if there has been prior isotope therapy, whole pelvic radiotherapy, or prior radiotherapy to at least 30% of the bone marrow.
8. Not eligible if there has been prior treatment with VEGF inhibitors or VEGF receptor inhibitors.
9. Not eligible if ECOG Performance status is more than 2.
10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

Phase II Study of a Weekly Schedule of BMS-247550 for Patients with Hormone Refractory Prostate Cancer

Eligibility Criteria (per Protocol Addendum #5, dated July 2007):

1. Histologically proven adenocarcinoma of the prostate gland.
2. Evidence of progressive metastatic disease (e.g., new lesions on bone scan or new/enlarging lesions on CT scan) or metastatic disease and rising PSA within 4 weeks prior to registration.
3. Subject must not have had prior radiotherapy within 4 weeks of randomization.
4. Subject must not have had prior Stronium 89, Samarium 153 or other radioisotope.
5. No concurrent use of estrogen, or estrogen-like agents (i.e., PC-SPES, Saw Palmetto, or other herbal products which may contain phytoestrogens), or any other hormonal therapy (including megastrol acetate, finasteride, ketoconazole, and sytemic corticosteroids) is allowed.
6. Adequate bone marrow function within 4 weeks of randomization.
7. Subject must not have any carcinomatous meningitis or brain metastases.
8. ECOG Performance status of 0, 1, or 2.
9. Subject must not receive any investigational agents other than BMS-247550 for the duration of his p articipation in this trial.
10. Other criteria, as determined by the protocol.

For more information about this trial, please contact Robin S. Stewart, RN, PhD, OCN, CCRC, at (863) 904-1900.

• Anemia
• Bladder Cancer
• Breast Cancer
• Colorectal Cancer
• Fallopian Tube
• Head and Neck
• Leukemia
• Lung Cancer
• Melanoma
• Myelodysplastic Syndrome
• Myeloma
• Pancreatic Cancer
• Prostate Cancer
• Renal Cell (Kidney) Cancer
• Thrombocytopenia
• Thromboembolism

© 2012 Lakeland Regional Medical Center