Gynecologic Oncology Clinical Trials

Last Updated 9/09/2013

Ovarian

Primary Therapy - Newly Diagnosed, untreated

• 2009-0186 (Bevacizumab + Carboplatin + Paclitaxel):  A phase II trial of bevacizumab with carboplatin and weekly paclitaxel as first-line treatment in epithelial ovarian, primary peritoneal, and fallopian tube carcinoma
• 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

Rare Tumors (Ovarian)

High-grade serous, recurrent

• 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

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

Clear cell, primary

• GOG 0268 (temsirolimus + carboplatin + paclitaxel followed by temsirolimus):  A phase II evaluation of temsirolimus (CCI-779) (NCI supplied agent: 683864, IND #61010) in combination with carboplatin and paclitaxel followed by temsirolimus (CCI-779) consolidation as first-line therapy in the treatment of stage III-IV clear cell carcinoma of the ovary   

Clear cell, recurrent platinum sensitive & platinum resistant

• GOG 0254 (SU11248 - sunitinib malate):  A phase II evaluation of SU11248 (sunitinib malate) IND #74019, NSC# 736511) in the treatment of persistent or recurrent clear cell ovarian carcinoma   

Mucinous, primary or recurrent, chemo naïve

• GOG 0241 (carboplatin + paclitaxel +/- bevacizumab vs oxaliplatin + capecitabine +/- bevacizumab):  A GCIG intergroup multicenter Phase III trial of open label carboplatin and paclitaxel +/- NCI supplied agent: bevacizumab (NSC #704865, IND #7921) compared with oxaliplatin and capecitabine +/- bevacizumab as first line chemotherapy in patients with mucinous epithelial ovarian cancer (MEOC)   

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)

• 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
• 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