Below are listings of Active Clinical Trials. For more information, please contact the Institutional Review Board (IRB), Human Research Protections Program at 954-355-4941.
updated: 07/13/2009
Breast
1. A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable & Operable Breast Cancer (NSABP-B40)
Eligible patients must have HER-2 negative breast cancer diagnosed by core needle biopsy with a palpable breast mass of greater > 2.0 cm. Patients will receive 1 of 6 preoperative therapy regimens, then surgery (lumpectomy or mastectomy), followed by potentially more Bevacizumab. The purposes of the study are to learn how breast cancer tumors respond to several different chemotherapy combinations with or without bevacizumab; to learn more about the side effects of the combinations of these drugs; and to collect tumor tissue before treatment for special testing that may help provide researchers with information about how tumors respond to chemotherapy.
2. A Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The Tailor X Trial (ECOG-PACCT-1)
Eligible patients must have HER2 negative, node negative, ER-Positive and/or PR-Positive breast cancer. Depending on the recurrence risk of the tumor, patients will receive either hormonal therapy alone vs. hormonal therapy and chemotherapy. The purpose of this study is to determine if a tumor with a medium recurrence risk will benefit from chemotherapy, & to confirm if tumors with a low recurrence risk will also have a very low risk of recurrence with hormonal therapy alone.
3. A Double Blind Phase III Trial of Doxorubicin/Cyclophosphamide followed by Paclitaxel with Avastin or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer (ECOG 5103)
Eligible patients must have histologically confirmed adenocarcinoma of the breast & must have completed definitive breast surgery. The purpose of this study is to determine if adding Bevacizumab to the current standard reduces the risk of recurrence compared to standard chemotherapy alone. Patients will receive Doxorubicin, Cyclophosphamide and Paclitaxel with our without Bevacizumab.
4. A Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer (SWOG S0307)
Eligible patients must have histologically confirmed primary invasive adenocarcinoma of the breast (Stage I, II, III) with no evidence of metastatic disease. The purpose of this study is to see if adding bisphosphonates to hormonal therapy or chemotherapy will help prevent cancer from spreading to the bones or other parts of the body. Patients will receive either Zometa IV, Clodronate pills, or Ibandronate pills.
5A. Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed By Paclitaxel Plus Trastuzumab with a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients with HER-2 Positive Operable Breast Cancer (ACOSOG Z1041)
Eligible patients must have HER-2-positive invasive adenocarcinoma of the breast diagnosed by core needle biopsy. The tumor/lesion must meet criteria for measurable disease, greater > 2.0 cm. This study is being done to find out how Trastuzumab along with chemotherapy drugs combined in 2 different ways will affect your tumor. Patients will receive FEC-75 (5-FU, Epirubicin, & Cyclophosphamide) with or without Trastuzumab, followed by surgery, and potentially more Trastuzumab.
Gastrointestinal:
1. (Temporarily on Hold) A Randomized Phase III Study Comparing 5-FU, Leucovorin, and Oxaliplatin vs. 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence (ECOG E5202)
Eligible patients must have histologically confirmed adenocarcinoma of the colon with >8 lymph nodes evaluated & reported. This study is being done to compare the effects of chemotherapy with or without Bevacizumab, for stage III colon cancer patients with a high risk for recurrence. Patients with low risk tumors will not receive any treatment but undergo observation and patients at high risk will receive FOLFOX (Fluorouracil, Leucovorin, & Oxaliplatin) with or without Bevacizumab.
2. A Clinical Trial Comparing Preoperative Radiation Therapy and Xeloda with or without Oxaliplatin with Preoperative Radiation Therapy and CI 5-FU with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum (NSABP-R04)
Eligible patients must have a diagnosis of adenocarcinoma of the rectum obtained by a biopsy. The tumor must be either palpable by rectal exam or accessible by scope, clinically Stage II or Stage III with a clinically positive node >1.0cm. The purposes of this study are to see if taking Capecitabine is as good as the standard of treatment drug 5-Fluorouracil (5-FU); if adding Oxaliplatin to Capecitabine & 5-FU can improve how well these drugs work. Patients will receive 5-FU or Capecitabine with or with out Oxaliplatin on days they receive radiation, followed by surgery.
Gynecological:
1. A Randomized Phase II Double Blind Trial of Carboplatin/Paclitaxel + Placebo vs. Carboplatin/Paclitaxel + Concurrent Bevacizumab Followed by Placebo vs. Carboplatin/Paclitaxel + Concurrent/Extended Bevacizumab in Women with Newly Diagnosed, Previously Untreated Stage III (Suboptimal) & All Stage IV Epithelial Ovarian or Primary Peritoneal Cancer (GOG 0218)
Eligible patients must have a histologic diagnosis of epithelial ovarian cancer or peritoneal primary carcinoma, FIGO stage III, with any gross (macroscopic or palpable) residual disease or FIGO stage IV defined surgically at the completion of initial abdominal surgery & with appropriate tissue available for histologic evaluation. This study is being done to compare the combination of Carboplatin/Paclitaxel & Bevacizumab to the standard combination of Carboplatin/Paclitaxel.
2. A Phase II Trial of Avastin with Docetaxel in Patients with Recurrence of Epithelial Carcinoma of the Ovary/Fallopian Tube/Peritoneum within 12 months of Platinum Therapy (Moffitt MCC 14920)
Eligible patients must have pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or fallopian tube cancer, with disease recurrence or progression occurring between 0-12 moths from prior platinum containing chemotherapy. The purpose of this study is to evaluate the effectiveness of the experimental combination of Avastin & Docetaxel in the treatment of women with platinum sensitive recurrent epithelial ovarian cancer within 12 months of platinum chemotherapy.
Lung:
1. A Phase II Trial of the Combination of Erlotinib and Bevacizumab In Never Before Smokers with Stage IIIB and IV Primary Lung Adenocarcinomas (SWOG S0636)
Eligible patients must have a diagnosis of biopsy proven adenocarcinoma of the lung, never smoked, and have had an incomplete or unresectable lung cancer. The purpose of this study is to find out what effects the combination of Erlotinib and Bevacizumab has on patients & their lung cancer.
2. A Randomized Phase III Study of Docetaxel or Pemetrexed with or without Cetuximab in Patients with Recurrent or Progressive Non Small Cell Lung Cancer After Platinum Based Therapy (ImClone CP02-0452)
Eligible patients must be diagnosed with advanced non-small cell lung cancer that has grown after receiving chemotherapy that included Cisplatin or Carboplatin. The purpose of this study is to test if adding Cetuximab to chemotherapy is better than chemotherapy alone in the control of your tumor & how long your tumor responds to treatment. Patients will receive either Docetaxel or Pemetrexed with or without Cetuximab.
Prostate:
1. A Phase III Study of Docetaxel and Atrasentan vs. Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer (SWOG S0421)
Eligible patients must have a histologic diagnosis of adenocarcinoma of the prostate which is measurable or non measurable & have evidence of bone metastases on a bone scan. The metastatic disease must also be deemed to be unresponsive or refractory to hormone therapy. The purpose of this study is to compare the effects of the combination of Docetaxel/Prednisone plus Atrasentan vs Docetaxel/Prednisone plus placebo on patients & their prostate cancer to see which is better.