Comparing First-line Therapies for Mucinous Ovarian or Fallopian Tube Cancer
Name of the Trial
Phase III Study of Carboplatin and Paclitaxel With Versus Without Bevacizumab Compared to Oxaliplatin and Capecitabine With Versus Without Bevacizumab as First-Line Therapy in Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Mucinous Epithelial Ovarian or Fallopian Tube Cancer (GOG-0241). See the protocol summary.
Dr. David Gershenson and Dr. Richard Penson, Gynecologic Oncology Group (GOG)
|Dr. David Gershenson|
Why This Trial Is Important
Mucinous ovarian cancer is a rare type of ovarian epithelial cancer, representing less than 5 percent of the roughly 21,000 cases of ovarian cancer diagnosed each year in the United States. This type of ovarian cancer tends to be detected earlier than the more common serous type of ovarian epithelial cancer, leading to a generally favorable prognosis. However, women with more advanced mucinous ovarian tumors typically fare worse than those with more advanced serous ovarian tumors. Researchers believe one possible explanation for this discrepancy is that mucinous ovarian cancer is biologically different from the serous type and is more similar to cancers of the gastrointestinal (GI) tract, such as colorectal or appendiceal cancers.
Because of the similarities between primary mucinous ovarian tumors and GI cancers, GOG researchers want to know if using combination chemotherapy with the drugs capecitabine and oxaliplatin, which is standard for advanced colorectal cancer, will improve the overall survival of women with advanced mucinous ovarian cancer compared with the current standard chemotherapy combination used for ovarian epithelial cancer, carboplatin plus paclitaxel. They also want to know if adding the antibody bevacizumab to either regimen will benefit patients. Bevacizumab has been shown to improve outcomes in colorectal cancer when added to capecitabine/oxaliplatin and in ovarian epithelial cancer in general when added to paclitaxel/carboplatin.
In this trial, which is being conducted in both the United States and the United Kingdom, women with stage II to IV or recurrent stage I mucinous epithelial ovarian or fallopian tube cancer will be randomly assigned to receive either paclitaxel/carboplatin with or without bevacizumab or oxaliplatin/capecitabine with or without bevacizumab. In addition to looking for differences in overall survival, doctors will monitor the patients in the four treatment groups for differences in progression-free survival, tumor response rates, drug toxicity, and quality of life.
“The GOG Rare Tumor Committee, which guided the development of this study in the United States, is really focused on trying to develop better therapies for rare ovarian tumors because we don’t believe they should be lumped in with the more common high-grade serous ovarian cancers,” said Dr. Gershenson. “The purpose of this study is to try to identify a more effective and active treatment against mucinous carcinoma of the ovary.
“We really know a lot less about the molecular biology of mucinous ovarian tumors than we do about other rare ovarian tumors,” Dr. Gershenson added. “So another important aspect of this study is the collection of tissue for a tissue repository that we can use in the future to perform studies to learn more about the biology and genetics of mucinous carcinoma of the ovaries.”