Fox Chase Cancer Center physician leads new international treatment study for ovarian cancer

March 04, 2001

Philadelphia -- An international clinical study to evaluate new treatments for women with ovarian cancer is now open in the U.S., with plans for activation in the United Kingdom, Italy, Scandinavia, Australia, New Zealand, and other countries. This randomized study will compare the overall effectiveness of the standard treatment (a combination of paclitaxel and carboplatin) for ovarian cancer with recently developed chemotherapy combinations incorporating newer drugs.

Michael A. Bookman, M.D., a medical oncologist at Fox Chase Cancer Center in Philadelphia, Pa., is the lead investigator for this treatment study. It was developed by the Gynecologic Oncology Group, an organization dedicated to clinical research in gynecologic cancer, in collaboration with an international panel of experts and with assistance from the pharmaceutical industry. The study is sponsored by the National Cancer Institute (NCI).

In the United States during 2000, it is estimated that 23,100 women will be diagnosed with ovarian cancer and 14,000 women will die of the disease. In North America, Western Europe, and Scandinavia ovarian cancer accounts for approximately five percent of overall cancer deaths in women and is the most common cause of death among gynecologic tumors. Currently, there are no effective screening methods for the early detection of ovarian cancer, and the majority of women with the disease are diagnosed with advanced cancer that has already spread within the peritoneal cavity (abdomen). Despite improvements in overall survival using the standard combination of paclitaxel and carboplatin, the five-year survival rate for women with advanced disease remains less than 30 percent.

The primary objective of the international study is to compare overall survival and progression-free survival of each of the four experimental arms with the standard chemotherapy treatment of paclitaxel and carboplatin.

"Currently, surgery and chemotherapy for ovarian cancer is effective, but long-term cure is uncommon," said Bookman. "In this study, we hope to determine if adding any one of three promising drugs to the standard treatment will improve the effectiveness."

The drugs that will be studied are topotecan, gemcitabine, and liposomal doxorubicin (Doxil). "Each of these drugs has the ability to directly enhance the activity of carboplatin, which remains the single best drug available to treat ovarian cancer," Bookman added. "In addition, these drugs are already used individually to treat recurrent ovarian cancer, and have good activity in that setting."

As many as 4,000 women are expected to participate in this study, depending on the effectiveness of the different treatment regimens.

"An international study was proposed by the National Cancer Institute because of the large number of patients required to complete a valid study in a reasonable period of time," Bookman explained. "This study will allow us to get the answers we need sooner so that we can identify more effective treatments for this devastating disease, while designing more novel treatments for the next generation of clinical trials."

This chemotherapy study is divided into "doublets" (two drugs) or "triplets" (three drugs). Each of the treatment arms includes a total of eight courses. Each course will be repeated every 3 to 4 weeks. The possible treatments are 1) carboplatin and paclitaxel (standard therapy treatment), 2) carboplatin, paclitaxel, and gemcitabine, 3) carboplatin and gemcitabine followed by carboplatin and paclitaxel, 4) carboplatin and topotecan followed by carboplatin and paclitaxel, or 5) carboplatin, paclitaxel, and Doxil.

"Although the trial has five different treatment arms, the basic approach was to take the current standard treatment and add the three new drugs using doses and schedules that are safe and tolerable," Bookman said.

Some common side effects include low blood counts with increased risk of infection or bleeding, decreased appetite, hair loss, and fatigue. Other uncommon side effects include allergic reactions, muscle weakness or sores in the mouth.

The second purpose of the study is to determine whether response to chemotherapy and survival are different in patients with mutations in the BRCA1 and BRCA2 genes compared to patients without mutations in these genes. In addition, researchers want to determine whether there is a survival difference in women with and without a family history of ovarian cancer.

BRCA1 and BRCA2 mutations may be present in as many as 10-15% of women with ovarian cancer. Women with these mutations have an increased risk of developing breast or ovarian cancer, as do some of their close family members.
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To contact Fox Chase Cancer Center about this study, please call 1-888-FOX CHASE. For information about other hospitals or clinics participating in this study, please contact the NCI's Cancer Information Service at 1-800-4 CANCER.

Fox Chase Cancer Center, one of the nation's first comprehensive cancer centers designated by the National Cancer Institute in 1974, conducts basic and clinical research; programs of prevention, detection and treatment of cancer; and community outreach. For more information about Fox Chase activities, visit the Center's web site at www.fccc.edu.

Fox Chase Cancer Center

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