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Gynecologic Oncology Clinical Trials

Last Updated 12/09/2014

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

  • 2012-0759 (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
  • 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

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
  • 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
  • GOG-0229O (trametinib + AKT inhibitor): A randomized Phase II study with a Phase I lead-in to assess the antitumor efficacy of the MEK inhibitor trametinib alone or in combination with GSK2141795, an AKT inhibitor, in patients with recurrent or persistent 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
  • 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
  • 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

© 2014 The University of Texas MD Anderson Cancer Center