Gynecological
CERVICAL
Protocol: RTOG-0724
Contact: CPLORD@stvincent.org
Title: 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
Summary: Patients included in this study are those with cervical cancer that was removed by surgery and has spread to the lymph nodes or the connective tissue of the uterus. This study compares the effects of giving additional chemotherapy to patients after the usual treatment of chemotherapy and radiation for their cervical cancer. In this study the patient will receive either radiation plus cisplatin alone or radiation plus cisplatin followed by carboplatin and paclitaxel.
–
Protocol: GOG-0240
Contact: CEHERNAN@stvincent.org
Title: A Randomized Phase III Trial of Cisplatin Plus Paclitaxel With and Without NCI-Supplied Bevacizumab (NSC #704865, IND #7921) Versus the Non-Platinum Doublet, Topotecan Plus Paclitaxel, With and Without NCI-Supplied Bevacizumab, in Stage IVB, Recurrent or Persistent Carcinoma of the Cervix.
Summary: This study is for patients with cancer of the cervix that is not curable by surgery or radiation therapy. The purpose of this study is to compare the effectiveness, safety, and impact on health-related quality of life of 1) cisplatin and paclitaxel, 2) cisplatin and paclitaxel plus bevacizumab, 3) paclitaxel and topotecan, or 4) paclitaxel and topotecan plus bevacizumab.
–
Protocol: GOG-0263
Contact: SAMORRI1@stvincent.org
Title: Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, State I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy
Summary: The study is for patients with early-stage cervical cancer who have some risk factors for the cancer to return. The purpose of this study is to determine if weekly chemotherapy with cisplatin and simultaneous radiation therapy increases the time a patient lives disease-free compared to radiation therapy alone. The patient will receive either standard treatment with radiation therapy or standard treatment with radiation therapy with the addition of cisplatin chemotherapy.
ENDOMETRIAL
Protocol: GOG-0258
Contact: CEHERNAN@stvincent.org
Title: A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Versus Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma
Summary: This study compares the effects of two treatments in patients with endometrial cancer contained in the abdomen. One treatment, which is considered investigational, consists of cisplatin given together with radiation therapy followed by the drugs carboplatin and paclitaxel for 4 cycles. Another treatment, the current standard therapy, consists of carboplatin and paclitaxel given for 6 cycles without radiation therapy. This study will compare survival of patients receiving these two treatments and side effects of both treatments.
–
Protocol: GOG-0086P
Contact: SAMORRI1@stvincent.org
Title: A Three Arm Randomized Phase II Study of Paclitaxel/Carboplatin/Bevacizumab (NSC#704865, IND#7921), Paclitaxel/Carboplatin/Temsirolimus (NSC#683864, IND #61010) and ixabepilone (nsc#710428, ind# 59699) Carboplatin/ Bevacizumab as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer
Summary: The purpose of this study is to determine if the drug combinations of paclitaxel/carboplatin/bevacizumab, paclitaxel/carboplatin/temsirolimus or ixabepilone/carboplatin/bevacizumab work more effectively in treating patients with advanced or recurrent endometrial (uterine) cancer and to determine what side effects are caused by treatment with these drugs. Chemotherapy for this type of cancer usually consists of carboplatin and paclitaxel, which are given every three weeks for a total of six treatments. Patients will receive treatment with either: 1) the combination of paclitaxel, carboplatin, and bevacizumab followed by continued bevacizumab treatment until the patient’s tumor grows or the patient has unacceptable side effects (this is called maintenance treatment); 2) the combination of paclitaxel, carboplatin, and temsirolimus followed by maintenance temsirolimus treatment; or 3) the combination of ixabepilone, carboplatin, and bevacizumab followed by maintenance bevacizumab treatment. Maintenance treatment is given following a planned course of chemotherapy (in this case paclitaxel/carboplatin or ixabepilone/carboplatin) to assist in prolonging the time without evidence of cancer growth.
–
Protocol: GOG-0249
Contact: CEHERNAN@stvincent.org
Title: A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients with High-Risk, Early State Endometrial Carcinoma
Summary: This study is for patients with high-risk early stage endometrial cancer that appears to be confined to the uterus. Patients have had surgery, including hysterectomy (removal of the uterus), removal of the ovaries, and possible removal of pelvic and para-aortic lymph nodes. Following the patient’s surgery, the doctor has identified them to have risk factors related to the cancer that place them at greater risk for the cancer recurring. The purpose of this study is to compare the effects of radiation therapy to the pelvis versus vaginal radiation therapy combined with 3 cycles of the chemotherapy drugs paclitaxel and carboplatin to determine which works better in reducing cancer reoccurrence.
OVARIAN
Protocol: MORAb-003
Contact: SAMORRI1@stvincent.org
Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of MORAb-003 (farletuzumab) in Combination with Weekly Paclitaxel Therapy in Subjects with Platinum-Resistant or Refractory Relapsed Ovarian Cancer
Summary: The purpose of this study is to determine if paclitaxel works better when given with investigational drug MORAb-003 (farletuzumab) or if it works better alone for the treatment of ovarian cancer. MORAb-003 acts like an antibody to help the patient fight cancer. An antibody is protein the body produces that binds to the surface of a foreign invader, such as a virus or bacteria, to prevent it from damaging the body. This study will include only patients who have platinum resistant (meaning the condition has worsened within 6 months of receiving platinum treatment) or platinum refractory (meaning the condition has not improved or has worsened since the patient was receiving platinum treatment) ovarian cancer.
–
Protocol: MORAb-003-004
Contact: CEHERNAN@stvincent.org
Title: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum-Sensitive Ovarian Cancer in First Relapse
Summary: This study is for patients who had a relapse of epithelial ovarian cancer at least 6 months after their first post-surgical treatment of chemotherapy containing platinum (carboplatin or cisplatin). The purpose of this study is to determine if carboplatin and taxane, the chemotherapy drugs used to treat ovarian cancer, work better alone or when given with the investigational drug MORAb-003 (farletuzumab). The taxane-based chemotherapy drugs that will be used in this study are paclitaxel or docetaxel.
–
Protocol: GOG-0268
Contact: SAMORRI1@stvincent.org
Title: A Phase II Evaluation of Temsirolium (CCI-779) (NCI Supplied: NSC# 683864, IND# 61010) in Combination with Carboplatin and Paclitaxel followed by Temsirolimus (CCI-779) Consolidation as First-Line Therapy in the Treatment of State III-IV Clear Cell Carcinoma of the Ovary.
Summary: This study is for patients with newly diagnosed Stage III or Stage IV clear cell cancer of the ovary. The purpose of this study is to determine the effectiveness of the investigational drug temsirolimus in combination with paclitaxel and carboplatin in treating this type of cancer and to determine the types and severity of side effects caused by treatment with this drug.
–
Protocol: GOG-0255
Contact: CEHERNAN@stvincent.org
Title: A Phase II Randomized, Double Blind Trial of a Polyvalent Vaccine-KLH Conjugate (NSC 748933 IND #14384) + OPT-821 Versus Opt-821 in Patients with Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Who are in Second or Third Complete Remission
Summary: This study is for patients with ovarian, fallopian tube, or peritoneal cancer that has recurred on or after their initial treatment of surgery and chemotherapy. The patient has had a second or third complete clinical remission. The patient now has received at least one additional treatment and their tumor has shrunk to remission. The purpose of the study is to determine the effectiveness of a polyvalent vaccine (including GM2-KLH, Globo-HKLH, Tn-MUC1-32mer-KLH, and TF-KLH plus OPT-821) compared to a vaccine containing OPT-821 alone.
–
Protocol: GOG-0254
Contact: SAMORRI1@stvincent.org
Title: A Phase II Evaluation of SU11248 (Sunitinib Malate) in the Treatment of Persistent or Recurrent Clear Cell Ovarian Carcinoma
Summary: The purpose of this study is to determine the effectiveness and side effects of SU11248 (sunitinib malate) in treating this type of cancer.
–
Protocol: GOG-0252
Contact: CEHERNAN@stvincent.org
Title: A Phase III Clinical Trial of Bevacizumab with IV Versus IP Chemotherapy in Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: NCI-Supplied Agent: Bevacizumab (NSC #704865, IND #7921)
Summary: This study is for patients with epithelial, ovarian, fallopian tube, or primary peritoneal cancer. The purpose of the study is to compare the effectiveness and benefits of intravenous chemotherapy versus two different intraperitoneal (IP) treatment plans. Giving chemotherapy directly into the abdomen is called intraperitoneal chemotherapy. For IP chemotherapy a special catheter (tube) is placed in the abdominal cavity. The IP chemotherapy drugs are delivered through this catheter. Another purpose of the study is to compare how the patient’s type of cancer responds to one of three different chemotherapy regimens when given in combination with a newer drug bevacizumab. The drug bevacizumab has been around since 2004, but is considered new for the treatment of ovarian cancer.
–
Protocol: GOG-0241
Contact: SAMORRI1@stvincent.org
Title: A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI Supplied Agent: Bevacizumab (NSC #704865, IND #7921) Compared with Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients with Mucinous Epithelial Ovarian or Fallopian Tube Cancer (MEOC)
Summary: This study is for patients with newly diagnosed Stage II-IV or Stage I recurrent (for which the patient has never received prior chemotherapy) mucinous adenocarcinoma of the ovary or fallopian tube that requires chemotherapy. The purpose of this study is to compare the effectiveness of several different treatment lines. In this study, the patient will receive one of the following treatments: 1) oxaliplatin and capecitabine; 2) standard treatment with carboplatin and paclitaxel; 3) combination of oxaliplatin, capecitabine and bevacizumab; 4) combination of carboplatin, paclitaxel and bevacizumab.
OVARIAN, FALLOPIAN TUBE, OR PERITONEAL
Protocol: GOG-0213
Contact: CEHERNAN@stvincent.org
Title: A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination with Bevacizumab (NSC #704865, IND #7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Fallopian Tube and Peritoneal Primary Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865, IND #7921)
Summary: This study is for patients with ovarian, fallopian tube or peritoneal primary cancer that has recurred after original treatment. The first purpose of this study is to compare the combination of carboplatin, paclitaxel and bevacizumab to the standard combination of carboplatin and paclitaxel alone. Effectiveness of treatment will be measured in terms of survival, time without evidence of cancer growth and quality of life (wellness and physical functioning). A second purpose of this study is to determine if a second surgery to remove tumor followed by chemotherapy can increase the time that the patient remains disease free.
–
Protocol: GOG-0260
Contact: SAMORRI1@stvincent.org
Title: A Phase II Evaluation of Elesclomol Sodium and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer (IND 110072).
Summary: This study is for patients with ovarian, fallopian tube, or primary peritoneal cancer that has failed to respond to initial chemotherapies or has reoccurred after their surgery, radiation therapy, or other forms of therapy. The purpose of this study is to determine if the drugs elesclomol sodium and paclitaxel are effective in treating the patient’s type of cancer transition and the side effects caused by treatment with this drug combination.
–
Protocol: GOG-0262
Contact: CEHERNAN@stvincent.org
Title: A Randomized Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel in Combination with Carboplatin With or Without Concurrent and Consolidation Bevacizumab (NSC #704865, IND #7921) in the Treatment of Primary Stage III or IV Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer
Summary: This randomized phase III clinical trial studies two different dose schedules of paclitaxel to determine how well the dose schedules work in combination with carboplatin with or without bevacizumab in treating patients with Stage III or Stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. The purpose of the study is to determine if giving bevacizumab together with combination chemotherapy may kill more tumor cells and whether giving paclitaxel once every three weeks is more effective than giving paclitaxel once a week.
–
Protocol: GOG-0264
Contact: SAMORRI1@stvincent.org
Title: A Randomized Phase II Trial of Paclitaxel and Carboplatin Versus Bleomycin, Etoposide and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary
Summary: This study is for patients who have a type of cancer called a stromal tumor of the ovary. At the time of surgery, the tumor was found to be malignant, which means the cancer spread beyond the ovary. The purpose of this study is to determine whether treatment with the standard of care, paclitaxel and carbolated, is more effective at controlling the cancer than treatment with the drugs bleomycin, etoposide and cisplatin. Other purposes of this study are to determine what side effects are caused by treatment with these drug combinations and if inhibin levels (a blood test) are effective at determining if the patient is responding to treatment.
CERVIX, ENDOMETRIAL, OVARIAN, UTERINE
Protocol: Moffitt
Contact: CPLORD@stvincent.org
Title: Total Cancer Care™: A Partnership with High Risk and/or Diagnosed Cancer Patients for Life – 14690
Summary: This study is for patients undergoing surgery at the St.Vincent Indianapolis Hospital. The patient grants permission for St.Vincent Indianapolis Hospital to have access to the tissue removed, and they donate it to the Moffitt Cancer Center for use in research. This research will pursue improving cancer treatments and patients outcomes of cancer treatments, both current and future.
OVARIAN AND UTERINE
Protocol: GOG-0261
Contact: CEHERNAN@stvincent.org
Title: A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naïve Patients with Newly Diagnosed Stage I-IV Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus or Ovary
Summary: This study is for patients who have an agressive form of uterine or ovariancancer. It requires additional therapy because it has spread beyond the original disease site and/or has re-grown following surgery or radiation treatment. The purpose of this study is to compare the drugs carboplatin and paclitaxel to the standard treatment of (paclitaxel plus ifosfamide and mesna). In this study patients will receive either the combination of paclitaxel and carboplatin or the combination of ifosfamide and mesna plus paclitaxel. Mesna is a drug used to reduce undesired effects of chemotherapy drugs.
OVARIAN, FALLOPIAN TUBE, OR PERITONEAL
Protocol: CA163-196
Contact: SAMORRI1@stvincent.org
Title: A Phase III Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women with Advanced Endometrial Cancer Who Have Previously Been Treated with Chemotherapy
Summary: The primary purpose of this study is to compare the ability of chemotherapy drugs ixabepilone, doxorubicin, or paclitaxel to prolong the survival of patients with advanced, recurrent, or metastatic endometrial cancer. Arm A: Ixabepilone given through intravenously over 3 hours, once every 21 days OR Arm B: Paclitaxel given intravenously over 3 hours OR doxorubicin given intravenously over 3 to 30 minutes, once every 21 days.
–
Protocol: GOG-0229J
Contact: CEHERNAN@stvincent.org
Title: A Phase II Evaluation of Cediranib (RECENTIN; AZD2171, IND# 72740, NSC# 732208) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Summary: The purpose of this study is to determine the effectiveness and side effects of the drug Cediranib in treating recurrent endometrial cancer that has not responded to prior treatment.
–
Protocol: RTOG 0921
Contact: CPLORD@stvincent.org
Title: A Phase II Study of Postoperative Intensity Modulated Radiation Therapy (IMRT) with Concurrent Cisplatin and Bevacizumab Followed by Carboplatin and Paclitaxel for Patients with Endometrial Cancer
Summary: The purpose of this study is to determine the effectiveness of bevacizumab added to standard chemotherapy and intensity-modulated radiation therapy (IMRT) in the treatment of patients with newly diagnosed endometrial cancer who have had a hysterectomy.