Questions About Cancer? 1-800-4-CANCER

Featured Clinical Trials

Cancer Studies Highlighted in the NCI Cancer Bulletin
  • Posted: 02/09/2010

Optimizing Chemotherapy with Bevacizumab for Ovarian Cancer

Name of the Trial

Phase III Randomized Study of Bevacizumab in Combination with Intravenous Versus Intraperitoneal Chemotherapy in Patients with Stage II, III, or IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Carcinoma (GOG-0252). See the protocol summary 1.

Principal Investigator

Dr. Joan Walker
Dr. Joan Walker
Principal Investigator

Dr. Joan Walker, Gynecologic Oncology Group

Why This Trial Is Important

Women with ovarian cancer usually undergo surgery to determine the cancer's stage and to remove as much malignant tissue as possible. Following surgery, these women are treated with chemotherapy in an effort to eliminate remaining cancer cells.

Typically, chemotherapy for ovarian cancer is administered intravenously (IV) and travels throughout the body in the blood (systemic chemotherapy). Research 2 by the Gynecologic Oncology Group and others, however, has demonstrated that combining IV chemotherapy with the delivery of chemotherapy drugs directly into the peritoneal cavity (intraperitoneal, or IP, chemotherapy) is more effective in delaying cancer progression and helping patients live longer. Since tumors are often confined to the peritoneal cavity in patients with ovarian cancer (as well as in those with fallopian tube or primary peritoneal cancer, which are biologically similar diseases), IP chemotherapy may allow for a greater concentration of anticancer drugs in the area around the tumors while limiting side effects elsewhere in the body. Results 3 published in 2006 from a phase III trial showing a median increase in survival of 12 months for women treated with IV plus IP chemotherapy led NCI to issue a clinical announcement 4 encouraging use of the combined treatment.

Other recent developments in the treatment of ovarian cancer may offer benefits similar to those seen with IV plus IP chemotherapy while avoiding some of problems associated with it (such as increased toxicity and difficulty of administration). A recent phase III study 5 using the chemotherapy drug paclitaxel 6 intravenously on a weekly basis, along with IV carboplatin 7 given every 3 weeks, yielded improvements in progression-free and overall survival compared to the same drugs given every 3 weeks. Additionally, treatment with the angiogenesis inhibitor bevacizumab 8 has shown significant antitumor activity in phase II studies.

In this trial, patients with stage II, stage III, or stage IV ovarian epithelial, fallopian tube, or primary peritoneal cancer will be randomly assigned to receive one of three chemotherapy regimens:

  • IV paclitaxel weekly and IV carboplatin every 3 weeks
  • IV paclitaxel weekly and IP carboplatin
  • IV paclitaxel and IP cisplatin 9, followed by IP paclitaxel

All patients will receive IV bevacizumab during and following chemotherapy. Doctors want to know which of these three regimens is most effective in delaying progression and improving survival.

"This trial is designed to determine if IP therapy is still superior given the clinical advances seen with regimens using weekly IV paclitaxel and/or bevacizumab," said Dr. Walker. "The added benefit of weekly IV paclitaxel and bevacizumab, in combination, for women with ovarian cancer has the potential to be a very exciting advance."

For More Information

See the lists of entry criteria 10 and trial contact information 11 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.

Related Pages



Glossary Terms

angiogenesis inhibitor (AN-jee-oh-JEH-neh-sis in-HIH-bih-ter)
A substance that may prevent the formation of blood vessels. In anticancer therapy, an angiogenesis inhibitor may prevent the growth of new blood vessels that tumors need to grow.
fallopian tube (fuh-LOH-pee-in...)
A slender tube through which eggs pass from an ovary to the uterus. In the female reproductive tract, there is one ovary and one fallopian tube on each side of the uterus.
intraperitoneal chemotherapy (IN-truh-PAYR-ih-toh-NEE-ul KEE-moh-THAYR-uh-pee)
Treatment in which anticancer drugs are put directly into the abdominal cavity through a thin tube.
intravenous (IN-truh-VEE-nus)
Into or within a vein. Intravenous usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein. Also called IV.
peritoneal cancer (PAYR-ih-toh-NEE-ul KAN-ser)
Cancer of the tissue that lines the abdominal wall and covers organs in the abdomen.
peritoneal cavity (PAYR-ih-toh-NEE-ul KA-vuh-tee)
The space within the abdomen that contains the intestines, the stomach, and the liver. It is bound by thin membranes.
progression (pruh-GREH-shun)
In medicine, the course of a disease, such as cancer, as it becomes worse or spreads in the body.
stage II ovarian epithelial cancer (... oh-VAYR-ee-un EH-pih-THEE-lee-ul KAN-ser)
Cancer is found in one or both ovaries and has spread into other areas of the pelvis. Stage II is divided into stages IIA, IIB, and IIC. In stage IIA, cancer has spread to the uterus and/or the fallopian tubes. In stage IIB, cancer has spread to other tissue within the pelvis. In stage IIC, cancer is found in one or both ovaries and has spread to the uterus and/or fallopian tubes, or to other tissue within the pelvis. Also, one of the following is true: (1) cancer is also found on the outside surface of one or both ovaries; or (2) the capsule (outer covering) of the ovary has ruptured (broken open); or (3) cancer cells are found in the fluid of the peritoneal cavity (the body cavity that contains most of the organs in the abdomen) or in washings of the peritoneum (tissue lining the peritoneal cavity).
stage III ovarian epithelial cancer (...oh-VAYR-ee-un EH-pih-THEE-lee-ul KAN-ser)
Cancer is found in one or both ovaries and has spread outside the pelvis to other parts of the abdomen and/or nearby lymph nodes. Stage III is divided into stages IIIA, IIIB, and IIIC. In stage IIIA, the tumor is found in the pelvis only, but cancer cells that can be seen only with a microscope have spread to the surface of the peritoneum (tissue that lines the abdominal wall and covers most of the organs in the abdomen), the small intestines, or the tissue that connects the small intestines to the wall of the abdomen. In stage IIIB, cancer has spread to the peritoneum and the cancer in the peritoneum is 2 centimeters or smaller. In stage IIIC, cancer has spread to the peritoneum and the cancer in the peritoneum is larger than 2 centimeters and/or cancer has spread to lymph nodes in the abdomen. Cancer that has spread to the surface of the liver is also considered stage III ovarian cancer.
stage IV ovarian epithelial cancer (...oh-VAYR-ee-un EH-pih-THEE-lee-ul KAN-ser)
Cancer has spread beyond the abdomen to other parts of the body, such as the lungs or tissue inside the liver. Cancer cells in the fluid around the lungs is also considered stage IV ovarian cancer.
systemic chemotherapy (sis-TEH-mik KEE-moh-THAYR-uh-pee)
Treatment with anticancer drugs that travel through the blood to cells all over the body.

Table of Links

1http://www.cancer.gov/clinicaltrials/GOG-0252
2http://www.ncbi.nlm.nih.gov/pubmed/16437527
3http://www.ncbi.nlm.nih.gov/pubmed/16394300
4http://www.cancer.gov/newscenter/pressreleases/2006/ipchemotherapyrelease
5http://www.cancer.gov/ncicancerbulletin/092209/page2
6http://www.cancer.gov/cancertopics/druginfo/paclitaxel
7http://www.cancer.gov/cancertopics/druginfo/carboplatin
8http://www.cancer.gov/cancertopics/druginfo/bevacizumab
9http://www.cancer.gov/cancertopics/druginfo/cisplatin
10http://www.cancer.gov/clinicaltrials/GOG-0252#EntryCriteria_CDR0000650601
11http://www.cancer.gov/clinicaltrials/GOG-0252#ContactInfo_CDR0000650601
12http://www.cancer.gov/clinicaltrials/search
13http://www.cancer.gov/cancertopics/types/ovarian