The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on gynecologic cancers—ovarian, cervical, and endometrial malignancies. These studies are researching stem cell therapy; antiretroviral combination therapy; XPO1 antagonists; anti–programmed cell death protein 1 (PD)-1 targeted treatments; stereotactic body radiation; and tyrosine kinase inhibitors.
All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
Phase I
Study Title: Phase I Study to Determine the Effects of Mesenchymal Stem Cells Secreting Interferon Beta in Patients With Advanced Ovarian Cancer
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: MD Anderson Cancer Center
Purpose: To find the highest tolerable dose of human mesenchymal stem cells with interferon beta (MSC-INFβ) that can be given to patients with ovarian cancer and to test the safety of
MSC-INFβ
Primary Outcome Measures: Maximum tolerated dose of MSC-IFNβ; correlation between the number of MSC-IFNβ infused and the production of interferon-β and the number of MSC-IFNβ detected at the tumor sites via tumor biopsy pre- and post-treatment [time frame: 5 weeks]
Principal Investigator: Amanda L. Olson, MD, MD Anderson Cancer Center; (713) 792-8750
ClinicalTrials.gov Identifier: NCT02530047
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Study Title: A Phase I Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II–IVA)
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: Abramson Cancer Center of the University of Pennsylvania
Purpose: To determine the benefit of twice daily oral nelfinavir and weekly intravenous (IV) cisplatin in combination as radiosensitizers with daily whole-pelvic external-beam and intracavitary radiation brachytherapy in clinical stages IIA, IIB, IIIA, IIIB, and IVA cervical carcinoma limited to the pelvis
Primary Outcome Measures:
Number of adverse events [time
frame: 2 years]
Principal Investigator: Fiona Simpkins, MD, Abramson Cancer Center; (855) 216-0098, penncancertrials@emergingmed.com
ClinicalTrials.gov Identifier: NCT02363829
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Study Title: A Phase I Open-Label Study of the Selective Inhibitor of Nuclear Export, Selinexor (KPT-330) in Combination With Paclitaxel and Carboplatin in Patients With Advanced Ovarian or Endometrial Cancer
Study Type: Phase I/interventional/parallel assignment
Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center
Purpose: To test the safety of the investigational drug selinexor (KPT-330) in combination with carboplatin and paclitaxel chemotherapy in advanced ovarian or endometrial cancer
Primary Outcome Measures: Maximum tolerated dose [time frame: 1 year]
Principal Investigator: Vicky Makker, MD, Memorial Sloan Kettering Cancer Center; (646) 888-4224
ClinicalTrials.gov Identifier: NCT02269293
Phase II
Study Title: Phase II Open-Label Nonrandomized Trial of the Anti–PD-1 Therapy Pembrolizumab With First-Line Platinum-Based Chemotherapy Followed by 12 Months of Pembrolizumab Monotherapy for Patients With Stage III/IV Epithelial Ovarian Cancer
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: Medical College of Wisconsin
Purpose: To assess the progression-free survival in suboptimally cytoreduced epithelial ovarian/primary peritoneal/fallopian tube cancer treated with the novel combination of carboplatin every 21 days (triweekly)/weekly paclitaxel IV with pembrolizumab IV followed by maintenance pembrolizumab IV
Primary Outcome Measures: Progression-free survival of combination platinum-based therapy with anti–PD-1 therapy followed by maintenance anti–PD-1 therapy in patients with epithelial ovarian cancer [time frame: 24–48 months]
Principal Investigator: Denise Uyar, MD, Medical College of Wisconsin; (414) 805-6634, duyar@mcw.edu
ClinicalTrials.gov Identifier: NCT02766582
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Study Title: A Phase II Study for Stereotactic Body Radiation Therapy for Definitive Treatment of Locally Advanced Cervical Cancer
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: University of Texas Southwestern
Medical Center
Purpose: To determine whether stereotactic body radiation boost therapy is effective in women with locally advanced cervical cancer without an increased risk of acute gastrointestinal or genitourinary toxicity
Primary Outcome Measures: Primary tumor local control [time frame: 2 years]
Principal Investigator: Kevin Albuquerque, MD, University of Texas Southwestern Medical Center; (214) 645-8525
ClinicalTrials.gov Identifier: NCT02045433
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Study Title: A Phase II Study of Cabozantinib (XL184) in Recurrent or Metastatic Endometrial Cancer
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study how well cabozantinib-s-malate works in treating patients with recurrent or metastatic endometrial cancer
Primary Outcome Measures: Progression-free survival [time frame: from start of treatment to time of disease progression or death, assessed at 12 weeks]; response rate using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [time frame: up to 12 weeks posttreatment]
Principal Investigator: Neesha Dhani, MD, FRCPC, University Health Network–Princess Margaret Hospital; visit clinicaltrials.gov to see all recruiting locations and individual contact information
ClinicalTrials.gov Identifier: NCT01935934 ■
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.
