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.
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 to you 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 278: Evaluation of Physical Function and Quality of Life (QOL) Before and After Non-Radical Surgical Therapy (Extra Fascial Hysterectomy or Cone Biopsy with Pelvic Lymphadenectomy) For Stage lA1 (LVSl+) and lA2-lB1 (≤ 2CM) Cervical Cancer
Early stage 1 cervical cancer is usually treated with either a radical hysterectomy or a "simple" hysterectomy. Radical hysterectomy is associated with significant side effects and complications, which is associated with the amount of tissue that is removed. Non-radical surgical procedures, which include simple hysterectomy or a cone biopsy or LEEP with pelvic lymphadenectomy, are acceptable options for early stage cervical cancer.
The purpose of this study is to collect information on the side effects and complications in women who have one of the non-radical surgical procedures and compare this information to known side effects and complications of women who have had a radical hysterectomy. The study will also look at and compare the quality of life physically and sexually before and after non-radical surgery. For participants who undergo a cone biopsy (or LEEP) and pelvic lymphadenectomy, the study will also collect information about their plans to become pregnant, any concerns they have about future pregnancy, and how often they become pregnant in the future, if they become pregnant.
Principal Investigator: Mildred Ridgway, MD
GOG 274: A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation alone. The Outback Trial (ANZGOG 0902/GOG-0274/RTOG 1174)
This study is being done to try to determine which of two treatments improves the overall survival rate of cervical cancer patients and best reduces the chance of the cancer coming back, if it disappears as a result of study treatment. The study will also look at how the treatments affect patients and their quality of life, good and/or bad.
The two treatments being compared on this study are:
Adjuvant chemotherapy is considered experimental for this study but has been shown to reduce the risk of other types of cancer from coming back in other places of the body.
GOG 279: A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327) Concurrent with Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva (NCT #01595061)
Advanced vulvar cancer is an uncommon disease that is generally treated with extensive surgery that includes a vulvectomy and often removal of the pelvic lymph nodes as well as removal of nearby structures, such as the lower colon, rectum, bladder, uterus, cervix, and vagina. How much is removed depends on how far the cancer has spread.
The purpose of this study is to see if radiation therapy and weekly cisplatin and gemcitabine chemotherapy works well in treating the type of cancer you have, and to find out what side effects or surgical complications (if surgery can be done later) are caused by this treatment combination.
GOG 286B: A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC #91485) Versus Paclitaxel/ Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer (NCT #02065687)
The purpose of this study is to find out if the drug combination of paclitaxel, carboplatin and metformin works better than paclitaxel and carboplatin alone in treating advanced or recurrent endometrial cancer and to find out what side effects (good or bad) are caused by treatment with these drugs.
Paclitaxel and carboplatin are standard chemotherapy for advanced or recurrent endometrial cancer. These drugs work well for many patients but we want to find out if adding another drug to standard chemotherapy will work better. The combination of paclitaxel, carboplatin and metformin for the treatment of advanced or recurrent endometrial cancer is considered experimental.
Metformin is a medication used to treat diabetes. Both obesity and diabetes are strong risk factors for endometrial cancer. Recent evidence suggests that metformin may also kill cancer cells and be helpful in both the treatment and prevention of many cancers, including endometrial cancer. Metformin is FDA approved, but not for cancer treatment and is considered experimental for this study.
GOG 213: Phase III study randomized controlled trial of carboplatin and paclitaxel alone or in combination with bevacizumab followed by bevacizumab and secondary cytoreductive surgery in platinum-sensitive, recurrent ovarian, peritoneal primary and fallopian tube cancer
One purpose of this study is to compare treatment with the combination of carboplatin, paclitaxel and bevacizumab to the standard combination of carboplatin and paclitaxel alone. To see if the treatment works, we will look at survival, time without evidence of cancer growth, and quality of life. A second purpose of this study is to determine if a second surgery to remove tumor before starting the chemotherapy can increase the time that you remain without cancer. A second surgery will only be done if you are a good candidate for the surgery. Another purpose of this study is to test blood and tissue samples to see if we can learn how to predict who may respond to treatment, have side effects, or have a better chance of recovery. This part of the study is optional and you do not have to be in the optional part of the study to be in the main study.
NRG-GY004: Testing the use of a single drug (olaparib) or the combination of two drugs (cediranib and olaparib) compared to the usual chemotherapy for women with platinum sensitive ovarian, fallopian tube, or primary peritoneal cancer
This study is being done for platinum sensitive ovarian cancer that has not returned within 6 months of completion of platinum-containing chemotherapy. People who are not in a study are usually treated with surgery and/or chemotherapy. There are several FDA-approved chemotherapy drugs that are commonly used.
The purpose of this study is to compare the effects on the cancer from using either olaparib by itself or in combination with cediranib to the usual chemotherapy given for this type of cancer Usual chemotherapy are: carboplatin and paclitaxel; carboplatin and gemcitabine; or carboplatin and pegylated liposomal doxorubicin [PLD]. This study will allow the researchers to learn whether giving olaparib by itself or giving it in combination with cediranib is better, the same, or worse than the usual chemotherapy by observing both the effect of these treatments on the cancer as well as any side effects that patients may experience.
Both olaparib and cediranib have already been tested for safety; however, they are not part of the usual care for this type of cancer.
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.
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