FOR IMMEDIATE RELEASE
Wednesday, October 7, 1998
NCI Press Office
Questions and Answers About NCI's Research With Herceptin®
- Solid tumors: This is a phase I/pilot study of low-dose interleukin-2 plus Herceptin in solid tumors — i.e., most cancers with the exception of leukemias and lymphomas. Phase I studies involve a small number of patients, usually with advanced cancers, and test the safety of a new drug at various doses. This trial is being conducted through the Cancer and Leukemia Group B (Protocol ID:
- Ovarian or peritoneal cancer: This is a Phase II study of Herceptin in recurrent or refractory ovarian or primary peritoneal carcinoma. As of Aug. 31, it was closed to accrual in order to assess initial data, but it could reopen. Phase II studies test the effectiveness of a drug in particular kinds of cancer. This study is being conducted through the Gynecologic Oncology Group (Protocol ID: GOG-160).
11. Will NCI conduct other studies of Herceptin in breast cancer?
Yes. NCI will be working with Genentech to study the use of Herceptin at different stages of breast cancer and in combination with other agents. These new breast cancer trials are still in the planning stage. They will be carried out by investigators in academic institutions and NCI-sponsored cooperative clinical trial groups, including cancer centers, and could start enrolling patients before 1999.
12. What about other kinds of cancer?
NCI and Genentech hope to explore the use of Herceptin in a variety of malignancies, including gastric, endometrial, salivary gland, lung, pancreatic, prostate, and colorectal cancers and osteosarcoma. Not all patients with these types of cancer have high levels of HER2. But as many as 30 percent to 40 percent of patients with some of these tumor types may overexpress the protein and therefore be candidates for clinical trials with Herceptin.
13. Is NCI supporting studies of other anti-HER2 antibodies?
Yes. NCI is involved in early trials of other monoclonal antibodies directed against the HER2 protein. For example, several phase I studies sponsored by NCI are testing a HER2 antibody, designated 520C9xH22, produced by the Medarex Corporation in Annandale, N.J. Other early, NCI-sponsored studies are evaluating a different HER2 antibody, 2B1, from Chiron Corporation in Emeryville, Calif.
Studies with other monoclonal antibodies targeted against different proteins on cancer cells are also under way. For more information, call the CIS at 1-800-4-CANCER (1-800-422-6237). The NCI's clinical trial database, called PDQ, can be reached on the Internet by going to http://cancertrials.nci.nih.gov.
For more information about cancer visit NCI's main Web site for clinical trials at
Attached: Cancer Centers Participating in TRC-9801
Cancer Centers Participating in TRC9801: