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 + save

Date Added
March 13th, 2014
PRO Number
Pro00025562
Researcher
David Griffin
Keywords
Cancer, Cancer/Gynecological, Drug Studies
Summary

The purpose of this study is to find out if radiation therapy along with the addition of the drugs, cisplatin and gemcitabine, works in treating locally advanced squamous cell carcinoma of the vulva and to find out what side effects or surgical complications are caused by treatment with this combination.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II STUDY OF VTX 2337 (IND # 78, 416) IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN (PLD) IN PATIENTS WITH RECURRENT OR PERSISTENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER + save

Date Added
February 11th, 2014
PRO Number
Pro00022783
Researcher
William Creasman
Keywords
Cancer, Cancer/Gynecological, Women's Health
Summary

This study is for subjects with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has returned after treatment or did not respond to earlier treatment. The purpose of this study is to compare pegylated liposomal doxorubicin (PLD; a standard chemotherapy) to PLD in combination with VTX-2337 (a new type of drug that stimulates the immune system) to see if it helps cancer tumors stop growing or shrink, and if it helps women with these types of cancer live longer. PLD is an FDA-approved treatment for women with ovarian cancer. In prior studies, approximately 15–20% of women who received PLD for relapsed ovarian cancer experienced a temporary shrinkage or disappearance of their tumor. VTX 2337 is an experimental drug (not approved by the Food and Drug Administration, FDA) that stimulates the immune system and may help the body kill cancer cells. The combination of PLD plus VTX-2337 has been evaluated in a previous study of 13 patients. The study is still ongoing, but so far there is evidence that PLD + VTX-2337 may temporarily stop some patients’ tumors from growing (this happened in 6 patients), or it may help cancer tumors temporarily shrink and/or disappear (this happened in 1 patient).
In addition to the treatment part of this study, the researchers plan to test samples of your tumor and some of your blood. You cannot participate in this study if you do not agree to provide these specimens for this research. The purpose of this research is to examine the impact the study drugs have on tumor tissue and specific blood cells and substances.
Lastly, researchers want to know if one's genes (DNA) affect how the body responds to the experimental medication or how one's body breaks it down. Subjects will receive the study drugs as long as there is evidence that their tumor is not growing and they are not experiencing unacceptable side effects.

Institution
MUSC
Recruitment Contact
Anne Wulf
843-792-9190
wulf@musc.edu

The Lymphedema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients + save

Date Added
January 7th, 2014
PRO Number
Pro00023757
Researcher
David Griffin
Keywords
Cancer, Cancer/Gynecological, Non-interventional
Summary

The purpose of this study is to find out how often woman with gynecologic cancer may develop lower extremity lymphedema (swelling in the legs or a swollen leg) after undergoing surgery to remove the tumor and surrounding tissue.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

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) + save

Date Added
December 18th, 2013
PRO Number
Pro00016094
Researcher
Jennifer Young
Keywords
Cancer, Cancer/Gynecological
Summary

The objectives of this trial are to find out whether adjuvant chemotherapy (using two other drugs) after chemo-radiation will increase the chances of survival and reduce the risk of tumor recurrence in the pelvis and other places. The risk and severity of side effects and quality of life during and after treatment will also be evaluated and compared. This trial will help the researchers understand the safety and effectiveness of this new treatment regimen for cervical cancer.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A Phase II Evaluation of Dalantercept (NSC #757172, IND #116598), A Novel Soluble Recombinant Activin Receptor-Like Kinase 1 (ALK-1) Inhibitor Receptor-Fusion Protein, in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma + save

Date Added
December 17th, 2013
PRO Number
Pro00029786
Researcher
Whitney Graybill
Keywords
Cancer/Gynecological
Summary

This study is for female patients with recurrent or persistent ovarian, fallopian tube, or primary pertoneal cancer that has failed to respond to the initial chemotherapies given and has re-grown after surgery, radiatio therapy, or other forms of treatment. In this study, we are looking to see the effectiveness of the drug dalantercept (also known as ACE-041) in treating these types of cancers and to determine the types and severity of side effects this drug may cause. In this study you will be given the drug subcutaneously once every three weeks as long as you are not experiencing unacceptable side effects or your disease has not progressed. A subcutaneous injection is given in the fatty layer of tissues just under the skin.

Institution
MUSC
Recruitment Contact
Anne Wulf
843-792-9190
wulf@musc.edu

A Randomized Phase III Study Of Standard Vs. IMRT Pelvic Radiation For Post-Operative Treatment Of Endometrial And Cervical Cancer (TIME-C) + save

Date Added
November 19th, 2013
PRO Number
Pro00029828
Researcher
Samuel Cooper
Keywords
Cancer/Gynecological
Summary

This study is for adult female patients who have endometrial or cervical cancer that has a high risk of coming back in the pelvis or vagina. The purpose of this study is to test whether the use of a radiation therapy delivery technique called intensity-modulated radiation therapy (IMRT) can reduce the amount and severity of gastrointestinal side effects (such as diarrhea) that result from radiation, compared with standard radiation techniques. In this study, patients will get either the IMRT or the standard radiation. Patients in group 1 (often called "Arm A"), you will receive IMRT radiation therapy. This radiation technique is not the standard technique in this setting. The radiation therapy will be given once daily, 5 days a week, for 5-6 weeks. The treatment takes about 5-15 minutes each day. Patients may or may not receive weekly IV cisplatin chemotherapy (this will be decided by the study doctor). Patients in group 2 (often called "Arm B"), will receive standard three-dimensional radiation therapy. This is the standard radiation technique in this setting. The radiation therapy will be given once daily, 5 days a week, for 5-6 weeks. The treatment takes about 5-15 minutes each day. Patients may or may not receive weekly IV cisplatin chemotherapy (this will be decided by the study doctor).

Institution
MUSC
Recruitment Contact
Anne Wulf
843-792-9190
wulf@musc.edu

A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NCS# 123127) v. Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma + save

Date Added
October 17th, 2013
PRO Number
Pro00026910
Researcher
Jennifer Young
Keywords
Cancer, Cancer/Gynecological
Summary

This study is for patients who have a specific kind of uterine cancer; called a leiomyosarcoma that was found only in the uterus; and which has been completely removed by surgery. In this study, we are looking to see if giving chemotherapy with gemcitabine plus docetaxel, followed by doxorubicin, to patients whose leiomyosarcoma was found only in the uterus, decreases the chance that the leiomyosarcoma will come back (recur). In this study half the patients will be managed in the standard way, which is to follow them closely with CT scans, and see if the disease ever comes back. The other half of the patients will be treated with chemotherapy and also followed to see if the disease comes back. Patients will be asked to visit the office for follow up exams approximately every four months for the first three years and then every six months for the next two years after enrollment on this study. At the end of this five year period we would like to keep track of the participants' medical condition for the rest of their lives by calling once a year to see how they are doing.

Institution
MUSC
Recruitment Contact
Anne Wulf
843-792-9190
wulf@musc.edu

Using Serum HE4 and CA125 to Monitor the Therapeutic Effects in Ovarian Cancer Patients Based on Histological Subtypes + save

Date Added
October 8th, 2013
PRO Number
Pro00019893
Researcher
Yusheng Zhu
Keywords
Cancer, Cancer/Gynecological
Summary

This study is for female adult subjects with ovarian cancer. CA125 is a protein (compound made by the body) found in blood that is used to monitor treatments and disease progression in ovarian cancer patients. HE4 is also a protein that is used in the evaluation of ovarian cancer and disease monitoring. Both CA125 and HE4 are approved by the FDA to monitor the treatment of ovarian cancers. The purpose of this study is to investigate HE4 and CA125 expressions in different types of ovarian cancer and to evaluate the changes in HE4 and CA125 before and after treatment. A blood draw of approximately 5mL or 1 teaspoon will be taken from eligible subjects before surgery and before each course of chemotherapy to evaluate HE4 and CA125 expression.

Institution
MUSC
Recruitment Contact
Karie Olsen
843-792-3966
olsenk@musc.edu

Limited Access Phase I/II Trial Of Paclitaxel, Cisplatin And CTEP Supplied Agent ABT-888 (Veliparib) (IND#77840, NSC#737664) In The Treatment Of Advanced, Persistent, Or Recurrent Carcinoma Of The Cervix + save

Date Added
June 18th, 2013
PRO Number
Pro00026211
Researcher
Jennifer Young
Keywords
Cancer, Cancer/Gynecological
Summary

This study is for patients that have cervical cancer that has not responded
to prior treatment or has re-grown after prior treatment. The purpose of the first part of this study (called Phase I) is to test the safety and determine the
appropriate dose of ABT-888, given in a capsule form and also known as Velaparib, in combination with receiving cisplatin and paclitaxel intravenously (though a vein). The purpose of the second part of this study is to determine the effectiveness of ABT-888 in combination with intravenous (through the
vein, IV) cisplatin and paclitaxel. We will also be looking at the types and severity of side effects caused by treatment with this drug. ABT-888 inhibits the enzyme Poly ADP ribose polymyerase (PARP), which inhibits DNA repair and may lead to decrease in cancer cell activity. Currently ABT-888 is not FDA approved for treatment of your cancer and is considered experimental.
Participants will be asked to receive IV paclitaxel, IV cisplatin and take ABT-888 as long as there is evidence that the tumor is not growing and the participant is not experiencing any unacceptable side effects.
After participants are finished with this treatment, the study doctor will ask them to visit the office for follow-up exams every three months for the first two years and then every six months for the next three years after completion of their treatment with paclitaxel, cisplatin and ABT-888.

Institution
MUSC
Recruitment Contact
Anne Wulf
843-792-9190
wulf@musc.edu

A Phase III Randomized Controlled Clinical 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. + save

Date Added
May 2nd, 2013
PRO Number
Pro00023965
Researcher
Whitney Graybill
Keywords
Cancer, Cancer/Gynecological, Women's Health
Summary

This study is for subjects with ovarian, fallopian tube or peritoneal primary cancer that has come back after original treatment. In this study, subjects will be able to choose whether or not to receive bevacizumab with paclitaxel and carboplatin or gemcitabine and carboplatin treatment. If subjects elect to receive bevacizumab, they will receive it every three weeks beginning with the second cycle of therapy and will continue to receive bevacizumab alone after therapy every three weeks as long as there is no evidence that their tumor is growing or that they are experiencing unacceptable side effects.
The primary purpose of this study is to determine if a second surgery to remove tumor followed by chemotherapy can increase the time that subjects remain disease free. If subjects' doctors feel that they are a good candidate for the second surgery they will be randomized to have surgery or not. A computer program will place subjects in one of the study groups. Neither subjects nor the doctor can choose the group they will be in. If subjects are randomized to receive the surgery it will be performed before chemotherapy is given. Chemotherapy will not be given until subjects recover from the surgery which could take up to six weeks.
Another purpose of this study is to test samples of subjects' blood, some of their tumor if left over from a previous surgery, and some of their tumor and normal tissue if left over from surgery performed as part of this study. The purpose of this research is to determine if this testing can be used in the future to determine which patients may respond to treatment, have side effects or have a good prognosis.
Subjects will receive chemotherapy treatment as long as there is evidence that they are benefiting from the therapy and are not experiencing unacceptable side effects up to a total of 8 treatments. If they choose to receive bevacizumab, subjects will receive this therapy in combination with chemotherapy. If subjects appear to be benefiting from treatment and have reached a maximum of 8 cycles of chemotherapy, they will receive bevacizumab as long as there is evidence that they are benefiting from the therapy and are not experiencing unacceptable side effects. Subjects will be followed by the study doctor for the rest of their lives. Subjects can withdraw from the study at any time.

Institution
MUSC
Recruitment Contact
Anne Wulf
843-792-9190
wulf@musc.edu