Gynecologic Oncology Clinical Trials

Last Updated 05/20/2016

Ovarian

Recurrent - Platinum Sensitive

  • GOG 0213 (secondary cytoreduction; physician’s choice chemo):  A phase III randomized controlled clinical trial of carboplatin and paclitaxel alone or in combination with bevacizumab (NSC #704865, IND #7921) followed by bevacizumab and secondary cytoreductive surgery in platinum-sensitive, recurrent ovarian, peritoneal primary and fallopian tube cancer

Recurrent - Platinum Sensitive/Platinum Resistant

  • 2013-0784 (AZD2014 or AZD5363): A phase Ib study of the oral PARP inhibitor olaparib with the oral mTORC1/2 inhibitor AZD2014 or the oral AKT inhibitor AZD5363 for recurrent endometrial, triple negative breast, and ovarian, primary peritoneal, or fallopian tube cancer
  • 2013-0207 (oral rucaparib):  A Phase 2, Open-Label Study of Rucaparib in Patients with Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
  • 2014-0522 (trabectedin, doxil):  A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Window-of-Opportunity Studies

  • 2015-0519 (AZD 1775): A Pilot Study of Wee1 Inhibition Induction Prior to Tumor Reductive Surgery in Ovarian Cancer

Rare Tumors (Ovarian)

Low-grade serous, recurrent, platinum sensitive & platinum resistant

  • GOG 0281 (trametinib vs physician choice chemo):  A randomized phase II/III study to assess the efficacy of trametinib (GSK 1120212) in patients with recurrent or progressive low-grade serous ovarian cancer or peritoneal cancer

Sex cord stromal, primary or recurrent, chemo naïve

  • GOG 0264 (paclitaxel + carboplatin vs bleomycin, etoposide, + cisplatin):  A randomized phase II trial of paclitaxel and carboplatin vs. bleomycin, etoposide, and cisplatin for newly diagnosed advanced stage and recurrent chemo-naive sex-cord stromal tumors of the ovary   

Endometrial

Primary Therapy (Newly Diagnosed, untreated)

  • 2014-0944  Phase II study of the levonorgestrel intrauterine device alone or in combination with the mTOR inhibitor, everolimus, for the treatment of complex atypical hyperplasia and stage Ia Grade 1 endometrial cancer
  • 2013-1035 A phase III Trial of postoperative chemotherapy or no further treatment for patients with node-negative stage I-II intermediate or high risk endometrial cancer

Advanced or Recurrent (Previously Treated)

  • 2013-0784 (AZD2014 or AZD5363): A phase Ib study of the oral PARP inhibitor olaparib with the oral mTORC1/2 inhibitor AZD2014 or the oral AKT inhibitor AZD5363 for recurrent endometrial, triple negative breast, and ovarian, primary peritoneal, or fallopian tube cancer

Cervical, Vaginal, Vulvar

Newly Diagnosed

  • RTOG0724 (chemo + pelvic radiation):  Phase III randomized study of concurrent chemotherapy and pelvic radiation therapy with or without adjuvant chemotherapy in high-risk patients with early-stage cervical carcinoma following radical hysterectomy
  • GOG 0274 (Outback Trial):  A phase II trial of adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone: The Outback Trial (ANZGOG 0902/GOG 0274/RTOG 1174)

Newly Diagnosed, Surgery Only

  • 2007-0800  A phase III randomized clinical trial of laparoscopic or robotic radical hysterectomy versus abdominal radical hysterectomy in patients with early stage cervical cancer
  • 2008-0118  Conservative surgery for women with low-risk, early stage cervical cancer

Recurrent or Persistent

  • NRG-GY002  A phase II evaluation of nivolumab, a fully human antibody against PD-1, in the treatment of persistent or recurrent cervical cancer

 

All Sites 

Advanced or Recurrent (Previously Treated)

  • 2010-0486 (bevacizumab + temsirolimus with carboplatin or paclitaxel or sorafenib):  Phase I trial of bevacizumab and temsirolimus in combination with 1) carboplatin, 2) paclitaxel, 3) sorafenib for the treatment of advanced cancer
  • 2011-0216  (siRNA-EphA2-DOPC): EphA2 Gene Targeting using Neutral Liposomal Small Interfering RNA Delivery (IND# 72924): A Phase I Clinical Trial
  • 2015-0035 (COTI-2): A Phase I Study of COTI-2 for the Treatment of Advanced or Recurrent Gynecologic Malignancies