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
May 28th, 2014
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 Randomized Phase II Study With A Phase I Lead-In To Assess The Antitumor Efficacy Of The MEK Inhibitor Trametinib Alone Or In Combination With GSK2141795, An AKT Inhibitor In Patients With Recurrent Or Persistent Endometrial Cancer. + save

Date Added
May 20th, 2014
PRO Number
Pro00034359
Researcher
Carolyn Britten
Keywords
Cancer/Gynecological, Women's Health
Summary

The purpose of this study is to determine the effectiveness of Trametinib alone or in combination with GSK2141795 in treating recurrent or persistent endometrial cancer and to determine the types and severity of side effects caused by treatment with these drugs.
Trametinib and GSK2141795 are both experimental drugs. Experimental means that the drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA) or similar regulatory agencies in foreign countries. These drugs are being evaluated in endometrial cancer because they act in ways which are thought to be important in the growth and survival of endometrial cancer.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

A pilot study evaluating vitamin D deficiency and risk of aggressive uterine cancer in African American as compared to White women + save

Date Added
May 19th, 2014
PRO Number
Pro00030938
Researcher
Whitney Graybill
Keywords
Cancer/Gynecological, Women's Health
Summary

The purpose of this study is to evaluate vitamin D levels in African American and White women who present with a new diagnosis of uterine cancer.

Institution
MUSC
Recruitment Contact
Tamara Saunders
843-792-6992
saundert@musc.edu

A Phase II Trial of DCTD-Sponsored Dasatinib (NSC #732517 IND #120636) In Recurrent/Persistent Ovary, Fallopian Tube, Primary Peritoneal, and Endometrial Clear Cell Carcinoma Characterized for the Retention or Loss of BAF250a Expression + save

Date Added
May 6th, 2014
PRO Number
Pro00033486
Researcher
David Griffin
Keywords
Cancer, Cancer/Gynecological, Drug Studies
Summary

This phase II trial studies how well dasatinib works in treating patients with persistent ovarian, fallopian tube, endometrial, or peritoneal cancer. Dasatinib may shrink patients' tumors by blocking some of the enzymes needed for cell growth.

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

Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials + save

Date Added
May 6th, 2014
PRO Number
Pro00034158
Researcher
Sharmila Mehta
Keywords
Cancer, Cancer/Brain, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Leukemia, Cancer/Lung, Cancer/Lymphoma, Cancer/Myeloma, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Education, Non-interventional
Summary

The purpose of this study is to find out if providing patients with educational materials helps them to be better prepared for making a decision about participating in a research study to treat their cancer.

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

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 + save

Date Added
April 30th, 2014
PRO Number
Pro00034096
Researcher
Whitney Graybill
Keywords
Cancer/Gynecological, Women's Health
Summary

This study is for adult women who have advanced or recurrent endometrial (uterine) cancer. The purpose is to find out if the drug combination of paclitaxel, carboplatin and metformin works better than paclitaxel and carboplatin alone in treating uterine cancer.

Institution
MUSC
Recruitment Contact
Sarah Booker
843-792-9190
bookers@musc.edu

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