Clinical Trial GOG 0213
- 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, Fallopian Tube and Peritoneal Primary Cancer
- Principal Investigator
- Emily Berry
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.GOG 0213
- The first purpose of this study is to compare the combination of carboplatin, paclitaxel and bevacizumab to the standard combination of carboplatin and paclitaxel alone. A second purpose of this study is to determine if a second surgery to remove tumor followed by chemotherapy can increase the time that patients remain disease free.
- Standard treatment for the types of cancer included in this study usually consists of two chemotherapy drugs, carboplatin and paclitaxel, which are given every three weeks for a total of six treatments. Chemotherapy is given to control the growth of cancer and to lower the chance of it coming back. Treatment with chemotherapy has been found to be effective, but long-term cure is uncommon. Many patients will eventually develop recurrent cancer and need additional treatment. A newer drug, called bevacizumab, has recently been approved by the U.S. Food and Drug Administration (FDA) for use in combination with chemotherapy in patients with colon cancer that has spread to distant sites in the body. Bevacizumab is thought to work by blocking the effect of Vascular Endothelial Growth Factor, (VEGF) a protein made by tumors which can stimulate growth of tumor cells as well as blood vessels in and around tumors in some patients. Bevacizumab has been given alone on a clinical trial for patients with ovarian and primary peritoneal cancer whose tumors have recurred (come back). Approximately 18% of the 62 patients' tumors have shrunk, and 39% have not grown in at least six months.
Some of the eligibility criteria include:
- Participants must have a diagnosis of epithelial ovarian cancer, peritoneal primary cancer or fallopian tube cancer that has recurred (come back) after prior therapy.
- Participants must have had a complete response to prior therapy (their cancer completely disappeared). Only one prior regimen is allowed.
- Participants must be 18 or older.
- Description of Treatment
- Participants participate in this study will receive one of the two possible chemotherapy combinations described below. Participants in the first group will receive the standard treatment which is carboplatin and paclitaxel given every three weeks IV (intravenous). The study drugs will be given every 21 days (one study cycle). They will continue to receive this treatment for a total of six cycles (18 weeks) as long as their cancer does not get worse and they do not experience unacceptable side effects. If a participant's cancer goes away while receiving treatment she will be given two more cycles of treatment up to a possible total of eight cycles (24 weeks). Participants in the second group will receive the standard treatment of carboplatin and paclitaxel IV with the addition of an experimental drug called bevacizumab given every three weeks (IV). They will continue to receive this treatment for a total of six cycles as long as their cancer does not get worse and they do not experience unacceptable side effects. If a participant's cancer goes away while receiving treatment she will be given two more cycles of treatment up to a possible total of eight cycles. In the second group participants will continue to receive the bevacizumab every three weeks as long as their cancer does not get worse and they do not experience unacceptable side effects.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103)(IND# 70177), Versus No Treatment Until Documented Relapse in Women with Advanced Ovarian or Primary Peritoneal Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
- A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus
- A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma
- A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naive Patients with Newly Diagnosed Stage I-IV, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus or Ovary
last updated: 14-Sep-14 09:00 PM
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