August 2013

Gynecologic Oncology Program at UNC Lineberger

 

UNC Gynecologic Oncology takes a multidisciplinary approach to the care of women with pre-invasive and invasive gynecologic cancers. Patients have access to the latest treatments for ovarian, uterine, cervical and vulvar cancers, as well as treatment of gestational trophoblastic neoplasia and other rare gynecologic cancers. Our team includes the physicians and nurses from the gynecologic oncology service as well as radiation oncology and surgical pathology.

On the forefront of minimally invasive and robotic surgery for gynecologic cancers, the UNC Gynecologic Oncology Program is internationally renowned as one of the premier gynecologic oncology programs in robotic and minimally invasive surgery, especially for endometrial and cervical cancers. Physicians can choose to use the robot, a laparoscope or an open incision to treat a patient. Treatment is tailored for each patient and type of gynecologic cancer.

To make a referral, call the Program Coordinator at 919-966-7822. For additional information, visit the program's website.

Find out more about the Gynecologic Oncology department's partnerships with referring physicians, what's new in gynecological cancer care, and the future of gynecological cancer treatment by watching this video of Linda Van Le, MD, Professor, UNC Division of Gynecologic Oncology.

Determining whether or not obesity and diabetes play a role in recurrent endometrial cancer

Dr. Victoria Bae-Jump is the National Principal Investigator for Gynecologic Oncology Group (GOG) 286B which is a two arm, randomized, placebo-controlled phase II/III trial designed to assess the efficacy and safety of metformin in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone in women with advanced and recurrent endometrial carcinoma.

Obesity and diabetes have been linked to poorer survival and increased recurrence rates in endometrial cancer. The anti-diabetic medication, metformin, has been shown to have anti-tumorigenic effects in pre-clinical studies, including those conducted by Dr. Bae-Jump in endometrial cancer. Metformin will be started at 850 mg a day for 4 weeks and if tolerated, will be increased to twice daily dosing for the remainder
of treatment. Metformin or placebo will be continued as maintenance therapy after completion of paclitaxel/carboplatin until disease progression.

One unique aspect of this trial is determining if it is possible to estimate possible differences in response rates, PFS, OS, and toxicity rates for the treatment regimens by the patients' level of obesity. This aims to answer the question of whether obesity and insulin resistance will predict responsiveness to metformin for cancer treatment. Some preclinical studies in animal models and pre-operative window trials suggest that metformin's effective action may be dependent on the metabolic composition of its host and may be more efficacious in obese and insulin resistant patients. Thus, Dr. Bae-Jump will explore this question in this clinical trial which makes this study innovative among the other ongoing metformin trials for cancer treatment.

The trial will be open for enrollment in Fall 2013.

(GOG 286B: A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin Versus Paclitaxel/Carboplatin/Placebo Initial Therapy for Measurable Stage III or IVA, Stage IVB, or and Recurrent Endometrial Cancer; PI: Bae-Jump)

Metformin for the treatment of endometrial hyperplasia, a precursor to endometrial cancer

Obesity and diabetes are strong risk factors for endometrial cancer and its precursor lesion, endometrial hyperplasia. Metformin, a generic oral anti-hyperglycemic, has been widely used to treat diabetes and gynecologic problems including anovulatory-related infertility and polycystic ovarian syndrome. Recent evidence suggests that metformin reduces cancer risk and cancer deaths among diabetic patients.

Based on preclinical in vitro and in vivo studies, metformin demonstrates anti-proliferative effects for both endometrial hyperplasia and cancer through inhibition of the mTOR pathway. The only available treatment options for endometrial hyperplasia are progestin therapy or hysterectomy. However, side effects of progestins include increased appetite and weight gain which are particularly detrimental in a population prone to obesity and the metabolic syndrome.

We hypothesize that metformin may offer an alternative treatment for endometrial hyperplasia and possibly confer secondary benefits including improvement in insulin resistance, weight loss, and normalization of menstrual cycles. Thus, we propose a pilot clinical trial to assess the efficacy of metformin in the treatment of endometrial hyperplasia without atypia.

The primary study objective is to estimate the response rate of endometrial hyperplasia without atypia by histopathological evaluation of endometrial biopsy following metformin treatment. Secondary outcomes will include patient compliance and tolerability. Potential biomarkers of treatment response will also be explored, including metabolic factors and molecular markers of downstream targets of the metformin/mTOR signaling pathway. This study is the first clinical trial to evaluate metformin for the treatment of endometrial hyperplasia, and if promising, would lead to a phase II clinical trial for this disease.

(LCCC1205: Metformin for the Treatment of Endometrial Hyperplasia: Pilot Clinical Trial;
PI: Bae-Jump)

More clinical trials in Gynecologic Oncology

FIRESDetermining the Sensitivity of Sentinel Lymph Nodes Identified with Robotic Fluorescence Imaging for Detecting Metastatic Endometrial and Cervical Cancer (PI: Jackson)

LCCC 0814: A Pilot Study Evaluating Phenotypic Measures of the Reticuloendothelial System as Predictors of Lopodox Pharmacokinetic and Pharmacodynamic Disposition (PI: Gehrig) 

LCCC 1015: Use of Palliative Performance and Symptom Distress Scales in Older Patients with Advanced Ovarian Cancer (PI: Van Le)

LCCC 1203: Changes in Functional Status and Mood in Patients Receiving Chemotherapy for Recurrent Ovarian Cancer (PI: Van Le) 

LCCC 1221: Hybrid PET/MR in the staging and therapy of cervical cancer: A pilot study (PI: Fielding)

MyFoodsWeb-Based 24h Recalls to Assess Habitual Diet Among Cancer Survivors: A Feasibility Study

TRINOVA-3: A Phase III Randomized, Double-Blind, Placebo-Controlled, Multi-Center study of AMG 386 with Paclitaxel and Carboplatin as First-Line Treatment of Subjects with FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers 

 

  Find us on Facebook  |   Follow us on Twitter  |   Watch us on YouTube

UNC Lineberger   N.C. Cancer Hospital   Clinical Trials   Clinical Programs   Comprehensive Cancer Support

 

For questions about all clinical trials at UNC, contact the UNC Lineberger Protocol Office at 919-966-4432 or (toll-free) 1-877-668-0683. For questions about clinical trials offered at other sites, contact the UNC Cancer Network at 919-966-7359 or (toll-free) 1-877-668-0683.

 

To make an appointment at the N.C. Cancer Hospital for one of your patients, visit our web page for referring physicians. You may also contact the Carolina Consultation Center at 1-800-862-6264.