Clinical Trials & Research in Gynecologic Cancer
Medical research is the engine that drives the medical school at the University of Colorado and particularly the Department of Gynecologic Oncology. Our cancer clinical trials and research efforts result in innovative care and more effective treatment for some of the most complex medical cases, as well as for more common gynecologic oncology conditions.
We couple that ingenuity with compassion to provide outstanding patient care and treatment results. The University of Colorado Gynecologic Oncology Division conducts more clinical trials and research than any other gynecologic oncology practice in the area. This allows us to provide the most up-to-date care to residents across the Rocky Mountain region backed by institutional studies
We are currently involved in clinical trials for cervical cancer, ovarian cancer, endometrial cancer and the effects of diet and exercise on gynecologic cancers. Those clinical trials are described below.
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Ovarian Cancer Clinical Trial
GOG 3015/Roche YO39523 (16-2745): Phase 3 Carbo/Taxol/Bev/Atezolizumab
CU Investigator: Kian Behbakht, MD
Participant eligibility
Detailed eligibility is reviewed after contacting the study team.
Recurrent Ovarian Cancer Clinical Trial
Astra Zenica Phase II (18-0595)
CU Investigator: Kian Behbakht, MD
PH 2 Open-Label to Assess Olaparib as a Treatment for Subjects with Different HRD Tumor Status with Platinum-Sensitive, Relapsed, High-Grade Ovarian, Fallopian or Primary Peritoneal
Participant eligibility
Detailed eligibility is reviewed after contacting the study team.
Recurrent Ovarian Cancer Clinical Trial
OncoMed (16-1225)
CU Investigator: Brad Corr, MD
Phase 1b Study of OMP-305B83 plus Weekly Paclitaxel in Subjects with Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Participant eligibility
Detailed eligibility is reviewed after contacting the study team.
Recurrent Ovarian Cancer Clinical Trial
NRG GY009 (17-1511)
CU Investigator: Kian Behbakht, MD
Randomized Phase II/III of PLD and Atezolizumab vs plus PLD/Bev/Atezo vs PLD/Bev for Platinum Resistant Ovarian cancer.
Participant eligibility
Detailed eligibility is reviewed after contacting the study team.
Cervical/Vulcar Cancer Clinical Trial
NRG-GY006 (16-0493)
CU Investigator: Kian Behbakht, MD
Phase II RT and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer.
Participant eligibility
Detailed eligibility is reviewed after contacting the study team.
Reducing UTI rates in surgeries using a catheter clinical trial
NCT03101371: Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
CU Investigators: Dina Flink, Ph.D. and Saketh Guntupalli, MD
Following a surgery using a catheter, urinary tract infection (UTI) complications remain high. It has been shown that using an aseptic protocol drastically reduces UTI incidence by 50 percent. Reducing UTIs will prevent readmission, extended hospital stays and antibiotic use associated with this complication. It will also improve cost effectiveness of care. The investigators hypothesize that they can reduce the incidence of UTIs after catheter placement with the implementation of a quality improvement (QI) protocol to prevent excess exposure to the environmental exposure of the catheter before, during and after insertion.
Participant eligibility
Participant eligibility includes the following criteria:
- Women 18-89 years old
- Admitted for surgery lasting >1 hour and requiring urinary catheter
- Have normal urine analysis within 24 hours pre-surgery
- Able to provide informed consent.
Enrolling soon, contact Dina Flink, Ph.D.
- 303-724-8467
- [email protected]
Learn more at ClinicalTrials.Gov
Vulvar Intraepithelial Neoplasia (VIN) clinical trial
NCT02875561: Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia (VIN)
CU Investigator: Dina Flink, Ph.D.
Despite the rise of vulvar intraepithelial neoplasia (VIN) among women, a standard of care for optimal treatment is lacking. Employing a randomized control trial, this phase III study (meaning the treatment has been tested successfully on a small number of patients and is ready to be tested on a larger number) will help determine the effectiveness of more targeted therapies for VIN.
Researchers hypothesize that treatment for VIN with ultrasonic aspiration will reduce recurrence rates of VIN by 60 percent over 12 months as compared with CO2 laser aspiration.
Both the Sonopet Ultrasonic Aspirator and the CO2 laser ablation devices are FDA approved devices for the treatment of vulvar dysplasia.
Participant eligibility
Participant eligibility includes, but is not limited to, the following criteria:
- Women 18-89 years old who have been diagnosed with high-grade VIN
- Referred for vulva sparing treatment for dysplasia
- Patients must be available for follow-up of treatment for 12 months
Enrolling now, contact Dina Flink, Ph.D.
- 303-724-8467
- [email protected]
Learn more at ClinicalTrials.Gov
GOG 3005: A Phase 3 placebo-controlled study of carboplatin/paclitaxel with or without concurrent and continuation maintenance veliparib (parp inhibitor) in subjects with previously untreated stages III or IV high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer
CU Investigator: Kian Behbakht, MD
The focus of this research study is to evaluate the safety and efficacy of veliparib in women with previously untreated, stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Participant eligibility:
Detailed eligibility is reviewed after contacting the study team. It includes, but is not limited to:
- Having stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, with the appropriate tissue available for histologic evaluation.
- Patients with high-grade serous adenocarcinoma.
- Patients who have not received prior radiotherapy or prior chemotherapy in the abdominal or pelvic area.
GOG 225: Diet and Exercise Effect on GYN Cancers
CU Investigator: Saketh Guntupalli, MD
This research studies whether diet and physical activity can modulate ovarian, fallopian tube and primary peritoneal cancer progression-free survival.
Participant eligibility:
Eligible criteria includes, but is not limited to:
- Women age 18 or older.
- Ovarian, fallopian tube or primary peritoneal cancer survivor with a history of stage II-IV.
- Completed cancer treatment within the past 6 weeks to 4 months.
- No clinical evidence of persistent or recurrent disease.
- No history of diet associated disease (renal, liver, etc.).
- Willingness to complete study questionnaires.
GOG 213: Carboplatin, Paclitaxel and Gemcitabine Hydrochloride with or without Bevacizumab after Surgery in Treating Patients with Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer (07-1235)
CU Investigator: Saketh Guntupalli, MD
This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride when given together with or without bevacizumab after surgery to see how well it works in treating patients with ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer that has come back. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer.
Participant eligibility:
Detailed eligibility is reviewed after contacting the study team and includes, but is not limited to, having a histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or fallopian tube carcinoma, which is now recurrent.
MILO –Array 162-311: A Study of MEK162 vs. Physician’s Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer
CU Investigator: Kian Behbakht, MD
This study compares the effectiveness of the investigational drug MEK162 with standard chemotherapy in women with low-grade serous ovarian, fallopian tube, or primary peritoneal cancer that has returned after being treated or persists despite treatment.
Participant eligibility:
Detailed eligibility is reviewed after contacting the study team and includes, but is not limited to:
- Women with low-grade serous ovarian, primary peritoneal or fallopian tube cancer that has returned after being treated or persists despite therapy.
- Patients with at least one prior regimen of platinum-containing therapy, but no more than three previous chemotherapy regimens.