The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on gynecologic cancers—cervical, vaginal, uterine, ovarian, and vulvar cancers. These trials are studying chemoradiotherapy combination treatments, cancer vaccines, intraperitoneal chemotherapy, intensity-modulated radiation therapy, and brachytherapy. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
PHASE I
Study Title: A Phase I Study of the Wee 1 Kinase Inhibitor AZD1775 in Combination With Radiotherapy and Cisplatin in Cervical, Upper Vaginal, and Uterine Cancers
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study the side effects and best dose of adavosertib when given together with external-beam radiation therapy and cisplatin in treating patients with cervical, vaginal, or uterine cancer
Primary Outcome Measures: Recommended phase II dose defined as the dose level with < 1/6 patients with dose-limiting toxicities [time frame: up to week 5]
Principal Investigator: Visit clinicaltrials.gov for a full list of investigators and site-specific contact information
ClinicalTrials.gov Identifier: NCT03345784
Study Title: A Phase I Study of Oncoimmunome for the Treatment of Stage III/IV Ovarian Carcinoma
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: UConn Health
Purpose: To test the safety and feasibility of the OncoImmunome vaccine—a tumor-specific vaccine formulation that is predicted to elicit tumor-protective immune responses—in patients with stage III/IV ovarian cancer
Primary Outcome Measures: Monitoring of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events v4.0 in subjects immunized with Oncoimmunome [time frame: 5 years]
Principal Investigator: Susan Tannenbaum, MD; contact Quratulain Ali, MPH, CCRP, (860) 670-7648, qali@uchc.edu
ClinicalTrials.gov Identifier: NCT02933073
PHASE II
Study Title: Heated Intraperitoneal Chemotherapy in Primary Ovarian Cancer Patients
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: University of Kansas Medical Center
Purpose: To evaluate the use of heated intraperitoneal chemotherapy for primary treatment of ovarian cancer at the time of surgical debulking and to assess whether intravenous (IV) chemotherapy can be started within 42 days of heated intraperitoneal chemotherapy and cytoreduction
Primary Outcome Measures: Time to start of IV chemotherapy [time frame: 42 days]
Principal Investigator: Andrea Jewell, MD; contact (913) 945-7552, ctnursenav@kumc.edu
ClinicalTrials.gov Identifier: NCT03321188
Study Title: A Phase II Trial Evaluating Cisplatin and Gemcitabine Concurrent With Intensity-Modulated Radiation Therapy in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Gynecologic Oncology Group, National Cancer Institute
Purpose: To study how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin in treating patients with locally advanced squamous cell cancer of the vulva
Primary Outcome Measures: Complete pathologic response evaluated as the frequency of complete clinical and pathologic response after primary therapy [time frame: 6 weeks]
Principal Investigator: Visit clinicaltrials.gov for a full list of investigators and site-specific contact information
ClinicalTrials.gov Identifier: NCT01595061
Study Title: Phase II Trial of Vaginal Cuff Brachytherapy Followed by Adjuvant Chemotherapy With Carboplatin and Dose-Dense Paclitaxel in Patients With High-Risk Endometrial Cancer
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: University of Oklahoma
Purpose: To determine the progression-free survival of patients with surgically staged, stages I to II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy
Primary Outcome Measures: Number of patients able to complete 6 cycles of treatment [time frame: 2 years]
Principal Investigator: Lisa Landrum, MD; contact Ingrid Block, (405) 271-8777, ingrid-block@ouhsc.edu
ClinicalTrials.gov Identifier: NCT03189446
PHASE III
Study 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
Study Type: Interventional/parallel assignment
Study Sponsor and Collaborators: Radiation Therapy Oncology Group, National Cancer Institute
Purpose: To study chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk, early-stage cervical cancer after radical hysterectomy
Primary Outcome Measures: Disease-free survival [time frame: from randomization to date of first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up; analysis occurs after 43 disease-free survival failure events on cisplatin/radiation therapy arm]
Principal Investigator: Visit clinicaltrials.gov for a full list of investigators and site-specific contact information
ClinicalTrials.gov Identifier: NCT00980954 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
