Gynecologic Oncology

Bev NeoAdjuvant

The objective of this study is to determine the feasibility of administering neoadjuvant carboplatin, placitaxel, and bevacizumab without excessive dose modification or cycle delay in patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. Secondary objectives are to describe the rate of optimal cytoreduction and the response rate in patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer treated with neoadjuvant carboplatin, paclitaxel and bevacizumab. Additional aims include describing the progression-free (PFS) and overall survival (OS) for women treated with these drugs, and assessing the quality of life for women treated with carboplatin, paclitaxel, and bevacizumab neoadjuvant treatment.

GOG212

The goal of this study is to determine whether CT-2103 or paclitaxel, administered to women with advanced ovarian, primary peritoneal or fallopian tube cancer who have attained a clinically-defined complete response to primary platinum/taxane-based chemotherapy (“consolidation/maintenance therapy”), will reduce the death rate, compared to re-treatment at the time of documented disease progression. In addition, the study aims to determine if, in this clinical setting, CT-2103 produces a more favorable toxicity profile (with a particular focus on peripheral neuropathy as measured by the GOG NTX4) and superior quality-of-life (as measured by the FACT-O), compared to paclitaxel. From a translational research perspective, the overall objective is to assess the clinical relevance of markers of angiogenesis in patients with advanced ovarian, primary peritoneal and fallopian tube cancer who achieve a clinically-defined complete response to primary platinum/taxane-based chemotherapy, and are randomized to CT-2103, paclitaxel, or no treatment until the time of documented disease progression.

GOG213

The goal of this study is to determine if surgical secondary cytoreduction, in addition to adjuvant chemotherapy, increases the duration of overall survival in patients with recurrent platinum- sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer. Furthermore, it aims to elucidate whether the addition of bevacizumab to the second-line and maintenance phases of treatment increases the duration of overall survival relative to second-line paclitaxel and carboplatin alone in patients with the aforementioned cancers. From a translational research perspective, the goal is to define molecular and biochemical profiles or determinants associated with the duration of progression-free survival in platinum-sensitive recurrent ovarian, peritoneal primary or fallopian tube carcinoma treated with combination chemotherapy with or without bevacizumab , followed with or without maintenance bevacizumab therapy in the presence or absence of secondary surgical cytoreduction.

GOG #262

Despite good initial responses to chemotherapy, 75% of ovarian cancer patients ultimately die of complications associated with disease progression. Consequently, there is a strong impetus to investigate new therapies to improve the outcome of patients afflicted with this deadly disease. Prior studies have shown that paclitaxel administered in a more continuous manner exhibits proapoptotic and antiangiogenic properties, increasing its antineoplastic effects. The purpose of this study is to determine if the weekly paclitaxel regimen increases the time until first progression or death (PFS) compared to the every-three-week paclitaxel regimen in women with primary stage II, III or IV epithelial ovarian, peritoneal or fallopian tube cancer, who are receiving carboplatin with or without bevacizumab.

GOG #249

At the State of the Science in Endometrial Cancer Meeting in Manchester, England, in November 2006, sponsored by the NCI, an international group of investigators was charged with defining what would be considered standard therapies and potential investigational therapies that could be explored in the management of endometrial cancer. Because of that meeting, this Phase III randomized trial was developed and supported by several participants. The purpose of this study is to determine if treatment with a promising experimental technique, vaginal cuff brachytherapy followed by three cycles paclitaxel + carboplatin chemotherapy, in patients with high-risk, early-stage endometrial cancer, reduces the rate of recurrence or death (i.e. increases recurrence-free survival) when compared to pelvic radiation therapy.

TRINOVA-1

This is Phase 3 clinical research study for women who have been diagnosed with recurrent, partially platinum-sensitive or resistant epithelial ovarian, primary peritoneal, or fallopian tube cancer. The objective of the investigation is to determine whether adding the study drug, AMG 386, to paclitaxel chemotherapy improves the outcome of treatment, compared to treatment with paclitaxel alone. AMG 386 is angiogenesis inhibitor, designed to slow down or stop the development of new blood vessels in cancer tissues. Approximately 900 women are enrolled in the clinical trial.

Pemetrexed (Alimta)/Carboplatin (Paraplatin)

Based on preclinical data, Pemetrexed is a promising agent for targeted ovarian cancer treatment. Carboplatin is an agent active in ovarian cancertreatment and has demonstrated antitumor activity when combined with Pemetrexed in other solid tumors. Normally, one of the standard treatments for ovarian, primary peritoneal or fallopian tube cancer is to administer Carboplatin alone. The goal of this study is to determine if adding Pemetrexed to Carboplatin in the treatment of recurrent ovarian cancer improves the tumor’s response to therapy compared to Carboplatin alone. An additional objective is to ascertain the type of side effects that can occur when these drugs are combined.

Ovarian Hipec

This is a Pghase 2, open-label, single-center study of intraoperative cisplatin in patients with recurrent ovarian, primary peritoneal or fallopian tube cancers. It aims to investigate the safety, tolerability and feasibility of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy for treatment of these carcinomas. The secondary objective of the study is to investigate the efficacy of surgical resection with HIPEC combined with repeated intraperitoneal chemotherapy for treatment of these diseases.