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Gynecologic Oncology Clinical Trials

Last Updated 04/15/2014

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
  • 2011-0951 (MK-1775 + paclitaxel + carboplatin vs. paclitaxel + carboplatin alone):  A Randomized, Phase II Study Evaluating MK-1775 in Combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin Alone in Adult Patients with Platinum Sensitive p53 Mutant Ovarian 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

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

  • 2012-0681 (oral BKM120 + oral olaparib):  Phase I study of the oral PI3Kinase Inhibitor BKM120 and the oral PARP Inhibitor olaparib in patients with recurrent triple negative breast cancer or high grade serous ovarian cancer
  • 2012-0759 (gemcitabine + pazopanib vs gemcitabine): A randomized open label phase II study of weekly gemcitabine plus pazopanib versus weekly gemcitabine alone in the treatment of patients with persistent or relapsed epithelial ovarian, fallopian tube or primary peritoneal carcinoma

Rare Tumors (Ovarian)

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

  • 2013-0209 (MEK162 vs physician choice chemo):  The MILO study (MEK Inhibitor in Low-grade serious Ovarian cancer): a multinational, randomized, open-label, phase 3 study of MEK162 vs. physician’s choice chemotherapy in patients with recurrent or persistent low-grade serous carcinomas of the ovary, fallopian tube or primary peritoneum

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)

  • 2008-0094 A phase II study of the Levonorgestrel Intrauterine Device (Mirena) to treat complex atypical hyperplasia and Grade 1 endometrioid endometrial carcinoma
  • 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 (Untreated)

  • 2011-0252 (dasatinib + paclitaxel + carboplatin):  Pilot and translational study of dasatinib (NSC #732517), paclitaxel and carboplatin in women with advanced stage and recurrent endometrial cancer

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

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)

  • 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

© 2014 The University of Texas MD Anderson Cancer Center