Clinical Trials
The WRAMC division of Gynecologic Oncology is a founding member of the Gynecologic Oncology Group (GOG), the premier multi-institutional cooperative cancer treatment group dedicated to the study and treatment of gynecologic malignancies. We are able to offer our patients access to more than 80 clinical and basic science related research protocols. Inquires should be directed to the Chief, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Walter Reed Army Medical Center, Washington, D.C. 20307, Phone 202-782-8432, FAX 202-782-9278. Additional information on clinical trials, such as detailed eligibility criteria for each individual study, can be found at the National Cancer Institute.
Clinical trials are organized studies conducted to answer specific questions about new treatments or new ways of using an already known treatment. Every study is conducted in a manor that answers very specific questions to try to increase medical knowledge and find new and better ways to treat patients. New cancer treatments must prove to be safe and effective in scientific studies with a certain number of patients before they can be made widely available.
It is estimated that only about 5% of eligible patients participate in clinical research. Patients take part in clinical trials for many reasons. Usually they hope for benefits for themselves. They may hope for a cure for their disease, a longer time to live or a way to feel better. Often they want to contribute to a research effort that may help others. Patients should choose if they want to take part in a study only after they understand both the possible risks and benefits. All patients in clinical trials are carefully monitored during and after participating in the trial.
Through clinical trials, researchers learn which approaches are more effective than others. A new treatment is always first studied in the laboratory. A new drug will be considered if it is found that it changes cells, or parts of cells, in a way that suggests that it will destroy cancer or help the body handle the side effects of cancer treatment. Based on what researchers learn from laboratory studies, and sometimes earlier clinical studies and standard treatments, as well, they design a trial to see if a new treatment will improve on current treatments.
Types of Clinical Trials
Clinical trials are carried out in phases, each designed to find out certain information. Patients may be eligible for studies in different phases depending on their general condition and the type and stage of their cancer. More patients take part in the later phases of studies than in the earlier ones.
1. Phase I Trials
In a Phase I study, a new research treatment is given to a small number of patients. The researchers must find the best way to give a new treatment and how much of it can be given safely. They watch carefully for any harmful side effects. The research treatment has been well tested in laboratory and animal studies, but no one knows how patients will react. Phase I studies may involve significant risks for this reason. They are offered only to patients whose cancer has spread and who would not be helped by other known treatments. Phase I treatments may produce anticancer effects, and some patients have been helped by these treatments.
2. Phase II Trials
Phase II trials are designed to find out if a cancer treatment actually kills cancer cells in people. Phase II trials usually involve 20 to 50 patients with one type of cancer. Any side effects of the treatment are watched closely, noted and assessed. New phases of clinical trials build and depend on information from earlier phases. A treatment showing activity against cancer in a Phase II trial will become part of a Phase III trial.
3. Phase III Trials
Phase III trials compare standard treatments (treatments that are most accepted for treatment of that cancer) with treatments that appear to be successful in the Phase II trials. Large numbers of patients are needed for Phase III trials, sometimes thousands of patients. Frequently, patients in these trials are randomized, or assigned by chance, to one of the treatments being studied. The "control group" is given the standard treatment. The other group receives the newer therapy and comparisons of results are studied.
Participation
Every clinical trial is designed to answer a set of research questions. If you fit the guidelines for a trial, you may be eligible to take part. Each study enrolls patients with certain types and stages of cancer and certain health status. You would most likely be referred to a trial by your own doctor or by a doctor who knows your case. Some patients find out about trials from other sources such as medical publications, other survivors or resources such as the internet. In any case, you must have a reasonable understanding of your role in a research study and be freely willing to take part in it.
Open Protocols
The following is a list of open GOG protocols by site:
Ovarian
GOG 175: A randomized Phase III trial of IV Carboplatin (AUC6) and Paclitaxel 175 mg/m2 Q 21 days x 3 courses plus low dose Paclitaxel 40 mg/m2/wk versus IV Carboplatin (AUC6) and Paclitaxel 175 mg/m2 Q 21 days x 3 courses plus observation in patients with early stage ovarian carcinoma
GOG 198: A randomized study of Tamoxifen versus Thalidomide (NSC# 66847) in patients with biochemical-recurrence-only epithelial ovarian cancer, cancer of the fallopian tube and primary peritoneal carcinoma after first line chemotherapy
GOG 199: Prospective Study of Risk-Reducing Salpingo-Oophorectomy and Longitudinal CA-125 screening among women at increased genetic risk of ovarian cancer
GOG 212: A randomized Phase III trail of maintenance chemotherapy comparing 12 monthly cycles of single agent Paclitaxel or Xyotax™ (CT-2103) (IND#70177), versus no treatment until documented relapse in women with advanced ovarian or primary peritoneal cancer chieve a complete clinical response to primary platinum/taxane chemotherapy
Endometrial
GOG 209: A randomized Phase III trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF versus Carboplatin/Paclitaxel in patients with stage III & IV or recurrent endometrial cancer
Gestational Trophoblastic Neoplasia (GTN)
GOG 174: A randomized Phase III trial of weekly Parenteral Methotrexate versus "Pulsed" Dactinomycin as primary management for low risk gestational Trophoblastic Neoplasia