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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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.

 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.

 Learn more at ClinicalTrials.Gov


Cervical cancer clinical trial

GOG 0274: A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared To Chemoradiation Alone (ANZGOG 0902)

CU Investigator: Saketh Guntupalli, MD

This international clinical trial is for women with locally advanced cervical cancer. It will evaluate whether giving cisplatin and radiation therapy together (with or without carboplatin and paclitaxel) reduces the risk of cancer recurrence and improves patient survival.

Participant eligibility

Detailed eligibility is reviewed after contacting the study team and includes, but is not limited to:

  • Women 18 years or older with advanced cervical cancer suitable for primary treatment with chemoradiation.
  • Patients who have not had prior chemotherapy or radiation therapy for cervical cancer.
  • Patients who have no prior history of Crohn’s disease, ulcerative colitis or any prior malignancies within 5 years.

Ovarian cancer clinical trials

GOG 9923: Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients with Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

CU Investigator: Kian Behbakht, MD

This phase I trial studies the best dose and side effect of veliparib when given in combination with carboplatin, paclitaxel, and bevacizumab while treating patients with newly diagnosed stage II-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cells to repair themselves from damage and survive.

Participant eligibility:

Detailed eligibility is reviewed after contacting the study team. All patients must have a diagnosis of epithelial ovarian, fallopian tube, primary peritoneal, or carcinosarcoma with appropriate tissue for histologic evaluation. Patients who have received prior chemotherapy for any abdominal or pelvic tumor within the last five years are excluded.

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.

Recurrent ovarian cancer clinical trials

SOLO 3: Phase III open label olaparib vs physician’s choice single agent chemo for BRCA1/2 mutations olaparib vs paclitaxel or topotecan or PLD or gemcitabine

CU Investigator: Kian Behbakht, MD

This open label, randomized study will assess the efficacy and safety of single agent olaparib vs. standard of care, based on physician’s choice of single agent chemotherapy (paclitaxel, topotecan, gemcitabine, and/or pegylated liposomal doxorubicin). The aim of the study is to assess the efficacy and safety of olaparib tablets.

Participant eligibility:

Detailed eligibility is reviewed after contacting the study team and includes, but is not limited to:

  • A histologically diagnosed relapsed high-grade serous ovarian cancer or high-grade endometrioid cancer.
  • Documented germline mutation in breast cancer susceptibility genes: BRCA1 and/or BRCA2.
  • At least 2 prior platinum based lines of chemotherapy.
  • Patients must be partially platinum sensitive or platinum sensitive. 

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.

Endometrial cancer clinical trials

GOG 3007: Everolimus and Letrozole vs hormonal therapy

CU Investigator: Saketh Guntupalli, MD

The main purpose of this study is to evaluate the effectiveness of the combination of the drugs Everolimus and Letrozole compared with Tamoxifen and Medroxyprogesterone acetate in treating endometrial cancer. Secondary objectives are to determine the types and severity of side effects caused by treatment with these drug combinations.

Participant eligibility:

Participant eligibility includes, but is not limited to, the following criteria:

  • Patients must have histologically confirmed advanced persistent, or recurrent endometrial carcinoma.
  • Prior chemoradiotherapy for a pelvic recurrence or adjuvant therapy is permitted for stage I, II or III disease.

GOG 277: Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients with High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery

CU Investigator: Saketh Guntupalli, MD

Uterine leiomyosarcoma which has not spread beyond the uterus is usually treated with surgery and patients are closely monitored and given chemotherapy only if the cancer returns. This phase II clinical trial studies whether giving chemo (gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride) after surgery but before the tumor returns can decrease the chance of recurrence. It is not yet known whether combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.

Participant eligibility:

To be eligible for this study patients must meet several criteria, including, but not limited to:

  • Patients must have had leiomyosarcoma that was surgically treated within 12 weeks of entering the study.
  • Patients may not have previously received gemcitabine, docetaxel or doxorubicin, nor radiation therapy to the pelvis.
  • Patients must be age 18 or older.