Gynecologic Cancer Clinical Trials

6 trials identified.

Tissue & Data Acquisition
Principal Investigator: Havrilesky, Laura
Protocol Number: PRO00013703

Age Group: Adult
Scope: National

Phase: 0
Disease Site: Corpus Uteri; Other Female Genital; Ovary

Contact: Lorenzo, Amelia
Phone:

What is the Condition Being Studied?
High-risk Endometrial Cancer or Ovarian/Tubal/Peritoneal Cancer who are about to get surgery
What is the Purpose of this Study?
We are doing this study is to collect specimens as well as data from women who are about to get surgery for a gynecologic cancer. 

The use of specimens and data in research can help us understand molecular changes in gynecologic conditions.  It may help us learn how to treat, prevent and care for gynecologic conditions such as cancer.
Who Can Participate in the Study?
Adult women who are scheduled to have surgery at Duke for:
- A gynecologic cancer diagnosis including high-risk endometrial, ovarian, peritoneal, or tubal cancer
- A pelvic mass that might be gynecologic cancer
- A recurrent gynecologic cancer
What is Involved?
If you choose to join this study, you will:
- Allow us to collect leftover tissue from your surgery, a small blood sample, and urine to use for future research
- Complete study questionnaires
- Agree for us to collect clinical data from your medical record related to your cancer and treatment
Participating Institutions:
  • Duke University Health System : Amelia Lorenzo
View this trial at ClinicalTrials.gov

GOG 0264: A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of The Ovary
Principal Investigator: Secord, Angeles
Protocol Number: PRO00022731

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Ovary

Contact: DCI Clinical Research Team, GYN Oncology
Email:

What is the Condition Being Studied?
Ovarian stromal cancer either newly diagnosed or known diagnosis without any chemotherapy
What is the Purpose of this Study?
We are doing this study to find out if treatment for ovarian cancer with paclitaxel + carboplatin (investigational chemotherapy) works as well and with fewer side effects than the standard chemotherapy option (bleomycin + etoposide + cisplatin (BEP).  
We are also interested to find out if a blood test could let us know about your treatment response.
Who Can Participate in the Study?
Adults who 
- Have a new diagnosis of advanced stage stromal ovarian cancer    
- Have been diagnosed with ovarian cancer within the past 8 weeks and have not had chemotherapy
- Are not pregnant or breastfeeding 
What is Involved?
If you agree to be in the study, you will: 
- Be randomized (put into one of two groups by chance like the flip of a coin) to receive investigational or standard chemotherapy  
- Be given either paclitaxel + carboplatin (the investigational therapy) through an IV for up to 4 hours every 21 days for 18 weeks (6 cycles) 
OR 
- One dose of bleomycin every 3 weeks + etoposide and cisplatin each daily for 5 days every 3 weeks through an IV for a total of 12 weeks (4 cycles) (the standard therapy)  
- Have a blood test before and during your treatment period  
- Have a chest x-ray and breathing test to look at your lung function  
- Be followed for 3-6 months for the first 5 years, then every year after you've completed treatment
Participating Institutions:
  • Duke University Health System : GYN Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

AdORN
Principal Investigator: Secord, Angeles
Protocol Number: PRO00079313

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Ovary

Contact: DCI Clinical Research Team, GYN Oncology
Email:

What is the Condition Being Studied?
Ovarian, fallopian tube, and peritoneal cancer
What is the Purpose of this Study?
We are doing this study to learn whether the investigational drug, atezolizumab, can be given with standard chemotherapy without delaying surgery for ovarian, fallopian tube and peritoneal cancer.
Who Can Participate in the Study?
Adult females who:
- Have not had prior treatment for advanced (stage III or IV) ovarian, fallopian tube, or primary peritoneal cancer
- Are eligible to get neoadjuvant (before surgery) chemotherapy for the treatment of their cancer and will be having one or more surgical procedures
What is Involved?
If you agree to be in the study, you will:
- Get a combination of atezolizumab, paclitaxel, and carboplatin every three weeks for nine weeks 
- Have surgery, followed by an additional nine weeks of atezolizumab, carboplatin, and paclitaxel

If your cancer does not get worse, you will get atezolizumab in the maintenance setting every three weeks for up to 18 months.
Participating Institutions:
  • Duke University Health System : GYN Oncology DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : GYN Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

UM1 10132 AZD1775 + Radiotherapy & Cisplatin in Cervical, Upper Vaginal, and Uterine Cancers
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00089135

Age Group: Adult
Scope: National

Phase: I (Cancer Control)
Disease Site: Other Female Genital

Contact: DCI Clinical Research Team, GYN Oncology
Email:

What is the Condition Being Studied?
Patients with cancer of the cervix, upper vaginal area or the uterus
What is the Purpose of this Study?
We are doing this study to test how safe different doses of a study drug called AZD1775 are given with the standard radiotherapy and chemotherapy.  
Who Can Participate in the Study?
Adults with cancer of the cervix, upper vaginal area or the uterus who are planning to receive whole pelvic radiotherapy
What is Involved?
If you join this study you will receive the study drug AZD1775 given with standard radiotherapy and cisplatin. 
The dose of the drug will be different for every group participating in the study.  
The dose will continue to increase for every group of study participants until side effects occur that require the dose to be lowered. 
Participating Institutions:
  • Duke University Health System : GYN Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

GOG-3020 ATHENA: Ovarian Cancer
Principal Investigator: Secord, Angeles
Protocol Number: PRO00100059

Age Group: Adult
Scope: National

Phase: III
Disease Site: Ovary

Contact: DCI Clinical Research Team, GYN Oncology
Email:

What is the Condition Being Studied?
High-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer
What is the Purpose of this Study?
We are doing this study to learn if the study drugs rucaparib and nivolumab are safe and will work on patients with ovarian, peritoneal and fallopian tube cancers. 

Rucaparib is an approved treatment for patients with advanced ovarian cancer. 

Nivolumab is a drug approved for treatment of some cancers, but not ovarian cancer. 

Who Can Participate in the Study?
Adult females who:
- Are newly diagnosed high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer that has responded to chemotherapy
What is Involved?
If you agree to be in this study, you will:
- Be randomized (like drawing numbers out of a hat) to one of four study drug options. These options include the use of a placebo, which is a sugar pill or an intravenous (IV) placebo. One of the study arms will not get a drug, using both the oral placebo and the intravenous placebo. 
--rucaparib (pill) + nivolumab (IV)
--placebo (pill) + nivolumab (IV)
--rucaparib (pill) + placebo (IV)
--placebo (pill) + placebo (IV)

- Get up to 25 cycles of the study treatments
- Return for follow-up visits at 28-days and 100 days after you have completed the study treatment
- Have long-term follow-up contact that will be made every 12 weeks until you have finished participation in this study
- Be involved in this study for about 5 years
Participating Institutions:
  • Duke Center for Living/Sarah Stedman Nutrition : GYN Oncology DCI Clinical Research Team
  • Duke Primary Care : GYN Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : GYN Oncology DCI Clinical Research Team
  • Duke University Health System : GYN Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Eisai Merck KEYNOTE-775 (Advanced Endometrial Cancer)
Principal Investigator: Secord, Angeles
Protocol Number: PRO00100905

Age Group: Adult
Scope: National

Phase: III
Disease Site: Other Female Genital

Contact: DCI Clinical Research Team, GYN Oncology
Email:

What is the Condition Being Studied?
Advanced endometrial cancer
What is the Purpose of this Study?
We are doing this study to learn what effects the study drugs, lenvatinib plus pembrolizumab, have on advanced endometrial cancer, when compared to standard chemotherapy. 

This study is also looking if it is safe to take the drugs lenvatinib plus pembrolizumab compared to treatment with standard chemotherapy using doxorubicin or paclitaxel.
Who Can Participate in the Study?
Adult females with advanced endometrial cancer who have been treated with at least one prior chemotherapy regimen
What is Involved?
If you choose to be in this study, you will:
- Be randomized (put into one of two groups by chance like a flip of a coin) to either:
--- Group 1: lenvatinib capsules and pembrolizumab infusion (study drugs)
--- Group 2: Get either doxorubicin or paclitaxel infusions 
- Get study drugs every 3 weeks for 3 cycles
- Have follow-up visits every 8 weeks with CT/MRI scans 
- Be in the study for up to 3 years and have 12 or more office visits to the clinic
Participating Institutions:
  • Duke Center for Living/Sarah Stedman Nutrition : GYN Oncology DCI Clinical Research Team
  • Duke Primary Care : GYN Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : GYN Oncology DCI Clinical Research Team
  • Duke University Health System : GYN Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov