California Diaglogue on Cancer

Clinical trials are research studies designed to find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer. Doctors all over the country are conducting many types of clinical trials. They are studying new and better ways to prevent, detect, and treat ovarian cancer. Through participation in these trials, women may receive access to new and investigational therapy options that are not available to women outside the clinical trial setting. Even if the women in a trial do not benefit directly, they may still make an important contribution by helping doctors learn more about ovarian cancer and how to control it. Clinical trial designs are all screened, approved, and monitored by national health authorities, and patients who enroll in clinical trials must be treated with the best available care. Although clinical trials may pose some risks, researchers do all they can to protect their patients. Researchers are conducting the following type of studies with women across the country:

• Prevention studies: For women who have a family history of ovarian cancer, the risk of developing the disease may be reduced by removing the ovaries before cancer is detected. This surgery is called prophylactic oophorectomy. Women who are at high risk of ovarian cancer are taking part in trials to study the benefits and harms of this surgery. Other doctors are studying whether certain drugs can help prevent ovarian cancer in women at high risk.

• Screening studies: Researchers are studying ways to find ovarian cancer in women who do not have symptoms.

• Treatment studies: Doctors are testing novel drugs and new combinations. They are studying biological therapies, such as monoclonal antibodies. Monoclonal antibodies can bind to cancer cells. They interfere with cancer cell growth and the spread of cancer. If you are interested in being part of a clinical trial, talk with your doctor.

Below are links to internet sites to where you can find more information on clinical trials or search current clinical trials that you may participate in.

National Cancer Institute
The National Cancer Institute leads a national effort to eliminate the suffering and death due to cancer. As part of its clinical research program, NCI enrolls thousands of people from around the country in over 150 clinical trials at the NIH Clinical Center. Below are three pages on the NCI’s Clinical Trials page.

Cancer Trials Support Unit
www.ctsu.org, 888-823-5923
The Cancer Trials Support Unit is a pilot project sponsored by the National Cancer Institute (NCI) to make NCI-supported cancer treatment trials available to physicians nationwide.

National Institute of Health
http://bethesdatrials.cancer.gov/default.aspx
The cancer-specific arm of the U.S. National Institutes of Health, this site offers comprehensive information about cancer clinical trials. The clinical trials conducted by the National Cancer Institute (NCI) on the NIH campus represent the core of the clinical program of the NCI's Center for Cancer Research (CCR).

ClinicalTrials.gov - U.S. National Institutes of Health
http://www.clinicaltrials.gov/
ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.

Coalition of National Cancer Cooperative Groups
www.cancertrialshelp.org, 877-520-4457
The Coalition of National Cancer Cooperative Groups is comprised of cancer clinical trial specialists and offers a variety of programs and information for physicians, patient advocate groups and patients. These programs are designed to increase awareness of, and participation in, cancer clinical trials.

Center for Information and Study on Clinical Research Participation
www.ciscrp.org, 888-CISCRP3
A non-profit organization focused on educating and informing the public about clinical research participation.

Acurian
www.acurian.com
Acurian recruits and enrolls thousands of patients for more than 60 pharmaceutical and biotech companies representing over 3,000 research sites.

Gynecologic Oncology Group
www.gog.org
The Gynecologic Oncology Group (GOG) is a non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of Gynecologic malignancies. The Group is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results.

The University of Texas - M. D. Anderson Cancer Center
http://utm-ext01a.mdacc.tmc.edu/dept/prot/clinicaltrialswp.nsf/disease
In the last 60 years, M.D. Anderson has built a worldwide reputationfor excellence in cancer patient care, research, education and prevention. The mission of M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

EmergingMed Clinical Trial Service
http://www.emergingmed.com/
EmergingMed is a confidential, secure, and free service to help you find and gain access to clinical trials that are testing new therapies for ovarian cancer. A single short, anonymous questionnaire easily answered by patients and family members is compared against the enrollment criteria for ALL of the clinical trials in the EmergingMed database in seconds. The resulting short list of clinical trials you might be eligible for can be printed out and discussed with your doctor. When you decide which of those trials you wish to pursue, EmergingMed will help you contact the right person at the location where the trial is being administered. Please be sure and read EmergingMed’s Privacy Policy.

The Ovarian Cancer National Alliance: Clinical Trials Matching Service http://www.ovariancancer.org/index.cfm?fuseaction=Page.viewPage&pageId=526
A comprehensive website that gives an overview of different types of clinical trials, the clinical trials process, key features of the clinical trials process, first hand experiences from patients who have participated in them, how to find a clinical trial and other useful resources on clinical trials.

DID YOU KNOW?
California Requires Health Plans to Cover Patient Care Costs in Clinical Trials

Legislation: Senate Bill 37, Effective: August 2001

What clinical trials are covered?
Phase I, II, III, and IV clinical trials with a therapeutic intent for patients with cancer and recommended by a treating physician. Trial must either involve a drug exempt from a New Drug Application (NDA) under federal regulations, or be approved by one of the following: National Institutes of Health (NIH), U.S. Food and Drug Administration, U.S. Department of Defense, U.S. Department of Veterans Affairs

Who is required to pay? All California insurers, including the state's Medicaid program and other medical assistance programs.

Other key criteria:
Plans may restrict coverage to services in California unless protocol is not provided at a California hospital or by a California physician.