For more information regarding these studies, contact Cancer Research and Registry at (601) 984‐1095.
GOG 263: A randomized phase III clinical trial of adjuvant radiation versus chemoradiation in intermediate risk, stage I/IIA cervical cancer treated with initial radical hysterectomy and pelvic lymphadenectomy
Cervical cancer is classified as low, intermediate, or high risk of recurrence based on what the tumor looks like. Women who are high risk are given radiation therapy and chemotherapy. Women who are intermediate risk are given radiation therapy alone.
The purpose of this study is to determine if weekly chemotherapy with Cisplatin and radiation therapy works better than radiation alone for intermediate risk and increases the time before the cancer comes back. The study will also look at side effects good and/or bad of these treatments.ents.
Principal Investigator: Kelly Wilkinson, MD
GOG/RTOG 0724: A phase III randomized study of concurrent chemotherapy and pelvic radiation therapy with or without adjuvant chemotherapy in high risk patients with early stage cervical carcinoma following radical hysterectomy
The purpose of this study is to compare the effects, good and/or bad, of giving the additional chemotherapy medicines carboplatin and paclitaxel after the standard treatment of cisplatin and radiation therapy. The study drugs carboplatin and paclitaxel are approved for other uses but not for treatment of early stage cervical carcinoma. This study will also look at biologic factors that may help predict and treat cervical cancer and will gather information about the effects of radiation therapy and chemotherapy on the overall quality of life. .
GOG 3009/ADXS001-02: A PHASE 3 STUDY OF ADXS11-001 ADMINISTERED FOLLOWING CHEMORADIATION AS ADJUVANT TREATMENT FOR HIGH RISK LOCALLY ADVANCED CERVICAL CANCER: AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence)
The purpose of this study is to determine whether your high risk cervical cancer will respond to a new drug called ADXS11-001. ADXS11-001 is an experimental drug that is intended to stimulate your immune system to respond specifically to the human papillomavirus (HPV) and cervical cancer. HPV comes in over 100 different types; persistent HPV infections are known to be the major risk factor for invasive cervical cancer. The experimental ADXS11-001 drug uses a live strain of the Listeria monocytogenes (Lm) bacteria that has been genetically modified to reduce the risk of infection and to express a gene from HPV that is designed to stimulate an immune response against your cervical cancer.
Also, this study is being done to determine if ADXS11-001 is safe and effective compared to Placebo in women with HRLACC. A placebo is an inactive substance that looks like the study drug but does not contain any active ingredients. The term “study drug” refers to both ADXS11-001 and placebo in this form.Principal Investigator: Kelly Wilkinson, MD
GOG 3015/YO39523: A PHASE III, MULTICENTER, RANDOMIZED,STUDY OF ATEZOLIZUMAB VERSUS PLACEBO ADMINISTERED IN COMBINATION WITH PACLITAXEL, CARBOPLATIN, AND BEVACIZUMAB TO PATIENTS WITH NEWLY-DIAGNOSED STAGE III OR STAGE IV OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER
The purpose of this study is to research the effects, good or bad, of atezolizumab on your specific type of cancer (ovarian, fallopian tube, or primary peritoneal).
Atezolizumab is a type of drug called a programmed death-ligand 1 (PD-L1) antagonist. It is an experimental drug, which means that the health authorities have not approved atezolizumab for the treatment of your specific type of cancer. However, atezolizumab is approved in the United States (U.S.) for the treatment of locally advanced or metastatic bladder cancer that came back after getting platinum-containing chemotherapy. Atezolizumab is also approved in the U.S. and in Europe for patients with non-small cell lung cancer whose cancer came back after getting either platinum-containing chemotherapy and/or a targeted therapy against their specific type of lung cancer.
Atezolizumab is an antibody that affects your immune system by blocking the PD-L1 pathway. An antibody is a large, Y-shaped protein used by your body’s immune system to identify and kill foreign objects, such as bacteria, viruses, and tumor cells. The PD‑L1 pathway is involved in the decrease of your body’s natural immune response to fight cancer. By blocking the PD-L1 pathway, atezolizumab may help your immune system to stop or reverse the growth of tumors.
In this study, you will also receive treatment with paclitaxel, carboplatin, and bevacizumab. These chemotherapy-based treatments are standard for patients with your specific type of cancer. In addition to these standard treatments, you will receive either atezolizumab or a placebo (in other words, an inactive substance that looks like atezolizumab).
Blood, tissue, and fluid samples, and related medical information collected during this study will be used by the Sponsor’s researchers and their partners to learn more about how atezolizumab affects your specific type of cancer.
Principal Investigator: Kelly Wilkinson, MD
Tesaro 3000-02-004: A PHASE 2, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF NIRAPARIB COMBINED WITH BEVACIZUMAB AS MAINTENANCE TREATMENT IN PATIENTS WITH ADVANCED OVARIAN CANCER, FALLOPIAN TUBE CANCER, OR PRIMARY PERITONEAL CANCER FOLLOWING FRONT-LINE PLATINUM-BASED CHEMOTHERAPY WITH BEVACIZUMAB
his study is being done to help find out if niraparib, in combination with bevacizumab, can help delay worsening of cancer in people who had a good response to earlier treatment with a platinum-type chemotherapy drug.The use of niraparib in combination with bevacizumab in this study is investigational. An investigational drug is one that is not approved by any regulatory authorities, including the United States Food and Drug Administration (FDA). However, niraparib has been approved by the FDA for the treatment of certain types of ovarian cancer. Bevacizumab has been approved by the FDA for treatment of multiple cancer types, including certain types of ovarian cancer, in combination with certain other treatments.Principal Investigator: Kelly Wilkinson, MD
NRY-GY005: A Randomized Phase II/III study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS)
This study is being done for recurrent platinum-resistant or –refractory ovarian cancer, defined as cancer that returned within 6 months of completion of platinum-containing chemotherapy, or continued to get worse during platinum-containing chemotherapy. People who are not in a study are usually treated with standard chemotherapy, or other investigational chemotherapy or biologic drugs. There are several FDA-approved chemotherapy drugs, and a biologic drug that is commonly used along with the chemotherapy.
This study has two parts: Phase II: The purpose of the Phase II part of the study is to compare any good and bad effects of using a combination of the investigational agents cediranib and olaparib, to using the standard chemotherapy, or cediranib alone, or olaparib alone.
Cediranib is an experimental drug that may help keep cancer cells from growing by affecting their blood supply. Olaparib is a drug that may stop cancer cells from growing abnormally. Olaparib by itself has been approved by the Food and Drug Administration (FDA) for use in women with advanced ovarian cancer with BRCA1 and BRCA2 mutation who have been treated with three or more different chemotherapy treatments. The combination of olaparib and cediranib is investigational. These drugs have been used in other research studies in ovarian cancer, and information from those other research studies suggest that these may help to keep cancer from growing.
This study will allow the researchers to know whether this different approach using two study drugs is better, the same, or worse than either drug alone or the usual chemotherapy approach. Standard chemotherapy drugs that are already FDA-approved for use in recurrent ovarian cancer include paclitaxel, topotecan, or pegylated liposomal doxorubicin (PLD). There will be about 200 people taking part in the Phase II study.
Phase III: The phase III part of the study will follow Phase II part and will also compare the use of a combination of the investigational agents cediranib and olaparib, to using the standard chemotherapy, or cediranib alone, or olaparib alone. Phase III will be used to confirm the effectiveness of a combination of cediranib and olaparib to the standard chemotherapy.
There will be about 350 people in the Phase III study.
Principal Investigator: Kelly Wilkinson, M.D
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