Research
Clinical Trials
Our division remains active and emphasizes participation in clinical trials. Most of our clinical trial participation is through the Gynecologic Oncology Group (GOG). Dr. Fowler has been the Principal Investigator for OSU in the GOG since 1997. However, we also participate in additional phase II pharmaceutical trials, as well as other novel clinical trials available only at the James Cancer Hospital. In addition to clinical trials, we are actively involved in basic science, translational and clinical research involving multiple important issues in gynecologic oncology. During FY2007-2008, our division had 35 active GOG trials and 4 pharmaceutical trials.
Dr. Cohn is the leader of the Gynecologic Oncology Disease Specific Team within the Comprehensive Cancer Center. Recently, Ohio State was awarded a contract through the National Cancer Institute (N01, Miguel Villalona, MD, as PI) to study novel therapeutics in phase II studies. Dr. Cohn is the leader of the gynecologic cancer section who will be responsible for the development of protocols to study these agents in patients with gynecologic malignancies. He is Principal Investigator for the National Cancer Institute project entitled, “Phase I/II study of intravenous and intraperitoneal administration of reovirus serotype 3- Dearing strain (Reolysin) in patients with recurrent or progressive platinum-resistant ovarian, tubal and primary peritoneal cancers”.
Division members are also the authors of several investigator initiated clinical trials including those that involve novel therapeutic agents. Dr. O’Malley is the Principal Investigator for “A Phase II Study of Paclitaxel/Carboplatin/Bevicizumab in the Treatment of Advanced Stage Endometrial Cancer”. Dr Copeland is the Principal Investigator for “A Phase II Study of Gemcitabine/Carboplatin/ Bevicizumab in Platinum-sensitive Recurrent Ovarian, Fallopian tube, or Primary peritoneal cancer”.
Drs. Cohn and O’Malley are the local principal investigators of many Phase II trials in ovarian cancer. Specifically, these trials evaluate novel therapeutic agents or new chemotherapy combinations. Dr. Fowler is a Co-PI on a Phase I study at Ohio State evaluating active immunotherapy with a HER2/neu peptide vaccine in patients with advanced gynecologic cancers. Collaborations with Tim Huang, PhD in the Department of Molecular Virology, Immunology & Medical Genetics into the epigenetic changes in ovarian carcinogenesis have led to submission of three abstracts for presentation at local and national meetings in 2006. Other research collaborative efforts in our division are outlined in the section on our gynecologic oncology fellowship.
In partnership with Walter Reed Army Medical Center, the Division of Gynecologic Oncology at the James Cancer Hospital was awarded $4.2 million beginning in June 2004, through June 2008. Dr. Fowler is the P.I. for this grant. The purpose of this program is to study epidemiologic, psychosocial and biologic factors in women diagnosed with gynecologic malignancies, emphasizing health care disparities. This program incorporates a sophisticated tissue/serum bank, psychological interventions, and novel biologic therapy modalities. While funding for this grant has formerly concluded, research projects related to the molecular biology of endometrial cancer will continue. Most importantly, the Division of Gynecologic Oncology in cooperation with the Department of Pathology will continue the tissue and serum and clinical data banks established for this project.
Dr. Cohn is a co-investigator in a trial entitled “Reducing cervical cancer in rural populations,” funded through the Centers For Population Health and Health Disparities. This study is aimed at determining the basis of increased cervical cancer rates in Appalachian Ohio, and establishing an intervention strategy to reduce the rates of cancer. Specifically, lay health educators will be introduced in communities to reduce rates of smoking and risky sexual activity in Appalachian women. Correlative basic scientific studies will evaluate the role of HPV in this population, as well as the immunologic basis of cervical neoplasia in these women. The study will continue through 2007. Dr. Cohn is also a co-PI with Dr. Richard Love for an American Cancer Society grant entitled “Angiogenic proteins in the blood and ovaries in premenopausal women undergoing surgical oophorectomy in mid-luteal phases of the menstrual cycle” and Principle Investigator of a grant entitled “Angiogenesis in ovarian cancer”. Other collaborative efforts led by Dr. Cohn as co-PI include a Phi Beta Psi Sorority National Project Grant with Dr. Christopher Weghorst entitled TGFBR1 genotyping for cervical cancer susceptibility” and as Principle Investigator on two other grants related to susceptibility of patients for cervical cancer from the American College of Obstetrics and Gynecology and from Perinatal Resources, Incorporated. In 2007, Dr. Cohn received the award for the best Basic Science Poster for work presented at the 2006 Society of Gynecologic Oncologists 2006 annual meeting.
Robotic-assisted surgery is an emerging technology which improves our ability over conventional laparoscopy to complete complicated minimally invasive procedures. The division of gynecologic surgery at OSU has accumulated one of the largest series of patients with gynecologic malignancies undergoing surgery with the assistance of the robotic platform. We have analyzed this experience, outcomes and compared this to other modalities such as laparoscopy and/or laparotomy. Multiple abstracts have been presented at national and international meetings and formal manuscripts are now being published in peer-reviewed journals on such topics such as feasibility, learning curve, outcomes in the obese patient and comparison to laparoscopy. Further research in progress includes a prospective analysis of post-operative pain and quality of life in patients undergoing robotic surgery versus laparotomy for staging of endometrial cancer and another study measuring physiologic changes a patient may experience during robotic surgery.
Multiple clinical projects have been performed and/or are presently active. This includes a large surgical-pathologic-clinical database in endometrial cancer collected in a prospective fashion. Analysis of this database has produced four clinical papers evaluating traditional outcomes in patients surgically staged with endometrial cancer. The tissue microarray constructed from this project continues to be used for correlative biomarker studies in endometrial carcinoma. Multiple translational projects are underway, including evaluating genetic risks and mechanism of disease, as well as the role of COX-2 and aromatase in endometrial cancer. Multiple clinical reports regarding our experience in patients with ovarian cancer have been published including the role of bevicizumab and second-line intraperitoneal chemotherapy. Ongoing translational research collaborations with members of the Human Cancer Genetics group has led to the publication of three manuscripts and many abstracts at local and national meetings describing the role of DNA mismatch repair in predicting outcomes of women with endometrial cancer.
Members of the division have a long history of mentoring fellows and residents in many such research projects. Over the past year, research has been presented by members of the division of gynecologic oncology at the following scholarly meetings; American Society of Clinical Oncology, American Society of Therapeutic Radiology and Oncology, Society of Gynecologic Oncologists, U.S. and Canadian Academy of Pathologists, Minimally Invasive Robotics Association, and Western Association of Gynecologic Oncologists.