Broward Health North
Clinical Trials

Clinical Trials

Broward Health North's Clinical Trials Program focuses on having available clinical trials to improve cancer care by finding better ways to treat cancer and help cancer patients. The decision to enroll in a clinical trial is voluntary and one that should be made with the close consultation of a physician.

For more information, please contact Darlene Booker, RN, CRCC, Senior Research Nurse, at 954-786-6736.
Radiation Oncologists
Pathologist
Research Nurse

The Comprehensive Cancer Center at Broward Health North is currently conducting the following clinical trials:

Clinical Trials List

Updated April 2013

Breast

C70305: A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer
Eligibility: Newly diagnosed with stage I-III cancer of the female breast. No prior history of carcinoma in situ, LCIS, DCIS, or invasive breast cancer.Patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis. Patients with basal cell and squamous cell cancer of the skin are eligible. Patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with presurgery measures (see Section 7.1) taken prior to receiving neoadjuvant therapy. Patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy.

Medical Oncology

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Brain

N107C: A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease
Eligibility: Four or fewer brain metastases (as defined on the pre-operative MRI brain scan) and status post resection of one of the lesions. Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site. Any unresected lesions must measure < 3.0 cm in maximal extent on the contrasted MRI brain scan obtained ≤ 35 days prior to pre-registration.

Radiation Oncology

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Colon

CALGB/SWOG C80702: A Phase III /trial of 6 Versus 12 Treatments of Aduvant Folfox Plus Celecoxib or Placebo for Patientswith Resected Stage III Colon Cancer  Protocol Description
Eligibility: Histologically documented adenocarcinoma of the colon. The gross inferior (caudad) margin of the primary tumor must be at least 12 centimeters from the anal verge (i.e., patients with rectal cancer are not eligible). Tumors must have been completely resected. At least one pathologically confirmed positive lymph node (or the AJCC version 7 designation of N1C defined as tumor deposit(s) in the subserosa, mesentery, or nonperitonealized pericolic or perirectal tissues without regional lymph node metastases).

Medical Oncology

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Head & Neck

RTOG 1016: Phase III Trial of Radiotherapy plus Cetuximab versus Chemoradiotherapy in HPV- Associated Oropharynx Cancer
Eligibility: Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls. Clinically or radiographically evident measurable disease at the primary site or at nodal stations (Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving < 4 nodes are permitted and considered as non-therapeutic nodal excisions. Fine needle aspirations of the neck are insufficient due to limited tissue for central review. Biopsy specimens from the primary or nodes measuring at least 3mm-5mm are required).

Radiation Oncology

BHN 001: A Prospectively Acquired Database of Head and Neck Cancer Patients Receiving Radiation Therapy using Modern Techniques with Quality of Life Assessment Tool within the Broward Health Medical System at 21st Century Radiation Oncology Offices and a retrospective Head and Neck Database Collection Study from 2011-2013
Eligibility: Newly diagnosed or recurrent head and neck cancer patients  who are undergoing curative daily fractionated radiation therapy using modern techniques including image guided radiation therapy (IGRT) and intensity modulated radiation therapy (IMRT) with or without chemotherapy in a upfront curative setting or an adjuvant setting following curative surgical resection

Radiation Oncology

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Lung

ECOG E5508 CIRB: A Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC
Eligibility: Cytological or histological confirmation of non-small cell lung cancer. Predominant non-squamous histology (patients with NSCLC NOS are eligible). Mixed tumors will be categorized by the predominant cell type. If small cell elements are present the patient is ineligible. Stage IV disease (includes M1a, M1b stages or recurrent disease) (according to the 7th edition of the TNM classification system). Patients with T4NX disease (stage III B) with nodule in ipsilateral lung lobe are eligible if they are not candidates for combined chemotherapy and radiation. No prior malignancy within the last 3 years with the exception of superficial melanoma, basal cell carcinoma or carcinoma in situ.

Medical Oncology

S0819 CIRB: A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or Without Concurrent Cetuximab in Patient with Advanced Non-Small Cell Lung Cancer
Eligibility: Must have histologically or cytologically proven newly diagnosed Stage IV, primary NSCLC. Patient may have measurable or non-measurable disease documented on CT or MRI.  The CT from a combine PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Patients must agree to submission of specimen for EGFR FISH testing and other translational medicine studies. No previous treatments with cetuximab, gefitinib, erlotinib or other investigational agents that target the EGFR pathway. No prior VEGF-related agents or prior chimerized or murine monoclonal antibody therapy or have documented presence of human anti-mouse antibodies (HAMA). Patient must have adequate renal, liver function and ANC ≥ 15000/mcl and Hb ≥9 mg/dl. Patient must have a Zubrod Perfermance Status of 0-1.

Medical Oncology

C30801 CALGB: Randomized  Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition In COX-2 Expressing Advanced Non-Small Cell Lung Cancer
Eligibility: Histologically or cytologically documented NSCLC Granulocytes ≥1,500/μl. Stage IV and selected stage IIIB. Tissue specimen required. No untreated CNS metastases. Measurable or non-measurable disease. No prior chemotherapy, immunotherapy or systemic treatments for NSCLC including adjuvant therapy.

Medical Oncology

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Prostate

RTOG 0924: Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer : A Phase III Randomized Trial
Eligibility: Have histologic proven diagnosis of adenocarcinoma of the prostate within 180 days of registration. Patient at moderate to high risk for recurrence as determined by one of the following combinations: Gleason score 7-10 + T1c-T2b (palpation) + PSA < 50 ng/ml (this includes both intermediate and high risk patients; Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/ml, or Gleason score 6 + > 50% positive biopsies + PSA < 50 ng/ml; Gleason score 6 + T1c-T2b (palpation) + PSA > 20ng/ml. More than 50% of the core biopsies positive. History and physical examination (including a digital rectal exam)  within 90 days prior to registration.

Radiation Oncology

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Other

(BONE METS) SWOG S0702: A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment.
Eligibility: Bone metastasis from multiple myeloma, solid tumor, or other malignancy where bisphosphonate is indicated. History of osteoclast inhibitor therapy for osteoporosis or osteopenia: Permitted: up to 3 doses of IV ibandronate, pamidronate, zoledronic acid or denosumab (Prolia) in the past 3 years. Any prior oral bisphosphonate. Osteoclast inhibitor therapy for metastatic bone disease - up to 180 days of prior osteoclast inhibitor for metastatic bone disease (ibandronate, pamidronate, zoledronic acid or denosumab. A total of no more than 10 doses of IV bisphosphonates or a total of 8 doses of denosumab are allowed. The combination of IV bisphosphonates and denosumab dosing may not be greater then 12 for any indication.

Medical Oncology

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Please call Research Nurse Darlene Booker, 954-786-6736 if you have qualified patients or any questions.

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More Information

For more information, visit clinicaltrials.gov ›

Clinical Trials

Clinical trials are studies in which people volunteer to take part in tests of new drugs or procedures. Doctors use clinical trials to develop new treatments for serious diseases such as cancer. On Cancer.org, you can learn about clinical trials in general, find tools to help you decide if a clinical trial may be right for you, and search for specific studies you may be eligible to take part in.

Learn more on Cancer.org ›

 

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