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Gynecologic Oncology Clinical Trials

Last Updated 07/29/2015

Ovarian

Primary Therapy - Newly Diagnosed, untreated

  • 2011-0800 (Propranolol with surgery or neoadjuvant chemotherapy): Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients

Recurrent - Platinum Resistant

  • 2013-0190 (demcizumab + paclitaxel):  A phase 1b/2 study of demcizumab plus paclitaxel in subjects with platinum resistant ovarian, primary peritoneal or fallopian tube cancer

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

Switch Maintenance - Platinum Sensitive

  • 2013-0208 (oral rucaparib): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients with Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or 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

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)

  • 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
  • 2012-0623 Prospective Evaluation of Lymph Node Metastasis at the time of Surgical Staging for High Risk Endometrial Cancer
  • 2008-0122 Prospective evaluation of robot-assisted surgery in gynecologic oncology
  • RTOG1203  A randomized phase III study of standard vs IMRT pelvic radiation for post-operative treatment of endometrial and cervical cancer (TIME-C)

Advanced or Recurrent (Previously Treated)

  • 2012-0543 (everolimus + letrozole + metformin):  A phase II, single-arm study of RAD001 (everolimus), letrozole, and metformin in patients with advanced or recurrent endometrial carcinoma
  • 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

Advanced or Recurrent (Untreated)

  • GOG 0286B (paclitaxel + carboplatin + metformin or placebo): A randomized phase II/III study of paclitaxel/carboplatin/metformin (NSC#91485) versus paclitaxel/carboplatin/placebo as initial therapy for measurable stage III or IVA, stage IVB, or recurrent endometrial 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
  • RTOG1203  A randomized phase III study of standard vs. IMRT pelvic radiation for post-operative treatment of endometrial and cervical cancer (TIME-C)
  • 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
  • 2010-0952  A phase III randomized study of pretherapeutic para-aortic lymphadenectomy in women with locally advanced cervical cancer dispositioned to definitive chemoradiotherapy

All Sites 

Advanced or Recurrent (Previously Treated)

  • 2014-0160 (AZD5363):  A Phase I, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies
  • 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

Window-of-Opportunity Studies

Ovarian

  • 2014-0474 (BMN 673): POSITION: A PilOt Study of InducTion PARP InhibitiON in ovarian cancer

© 2015 The University of Texas MD Anderson Cancer Center