A strong clinical research structure including a comprehensive program of clinical trials in treatment, early detection, and prevention is a critical component of the NCI research program. The components of the program include the Cancer Centers described above and the Cooperative Groups described in the following section. The Community Clinical Oncology Program (CCOP) is also a crucial component, extending the opportunity for participation in clinical trials to communities across the country. Hundreds of clinical trials are supported through these and other research mechanisms, such as individual research grants, program project grants, cooperative agreements, and contracts. Our ability to conduct clinical trials is in danger of being compromised by changes in the health care system. In the past, institutions have used surplus revenues from patient care services to supplement government research support. The growth of managed care has all but eliminated those discretionary funds. As a result, institutions can no longer sponsor research activities requiring capital expenditures and cannot support essential training for young investigators. These changes pose a very real danger for the continuation of cancer research and our ultimate success against cancer.
The nationwide Cooperative Groups program promotes and supports clinical
trials in cancer treatment, prevention, and early detection. More than 1,400
institutions and 8,500 investigators participate in these Cooperative Group
studies.
.
The NCI Role in the Development of Paclitaxel (Taxol®)
Paclitaxel is a plant-derived drug originally identified through the
NCI's natural products screening program and brought into clinical trials
by the NCI in the mid 1980s. The drug has been found to have important anti-tumor
activity in patients with ovarian and breast cancers. For example, protocol
GOG 111 by the Gynecologic Oncology Group, one of the NCI Cooperative Groups,
recently demonstrated a 50 percent increase in median survival time among
women with advanced ovarian cancer who were treated with the combination
of paclitaxel and cisplatin compared with the standard approach of cisplatin
with cyclophosphamide. The NCI has collaborated with Bristol-Myers Squibb
in the clinical development of paclitaxel under a CRADA (Cooperative Research
and Development Agreement).
The NCI Role in the Development of All-trans Retinoic Acid ("Vesanoid")
for Acute Promyelocytic Leukemia
Acute promyelocytic leukemia (APL) is a form of acute leukemia affecting
more than 500 individuals in the United States annually. The disease is
treated with aggressive chemotherapy associated with risks of fatal infections
and bleeding. Once initial chemotherapy approaches--sometimes including
bone marrow transplantation--have failed, the disease is frequently fatal.
Following research results from China showing complete disappearance of
malignant cells in patients receiving all-trans retinoic acid, an orally
administered modification of Vitamin A, the NCI moved rapidly to make the
drug available to patients with APL in whom initial chemotherapy had failed.
In collaboration with the pharmaceutical company Hoffman LaRoche, the NCI
obtained a clinical supply of all-trans retinoic acid. Over the last three
years more than 1,600 patients with relapsed APL have received the drug,
shipped overnight by the NCI after request by the treating hematologist
or oncologist. Information gathered from this experience was critical in
the FDA evaluation of the agent, and Vesanoid was approved by the FDA for
general availability in December of 1995. Meanwhile, an NCI-sponsored randomized
clinical trial involving the major adult and pediatric Cooperative Groups,
and evaluating the role of Vesanoid combined with chemotherapy in the initial
treatment of APL, has been recently completed. The results clearly demonstrate
the benefits of combining Vesanoid with available best chemotherapy, and
represent a major advance in the treatment of malignancy.
Greater patient access to advanced therapeutic approaches has been a chief goal of the NCI clinical trials program. The field of childhood cancers is one of the success stories in medicine in the twentieth century. About 70 percent of children who develop cancer in the United States annually are treated in the NCI-sponsored Cooperative Groups clinical trials. While the percentage of adults with tumors treated on protocols is much smaller (on the order of one percent), more than 8,500 oncologists participate in NCI trials, allowing patients to benefit from advanced treatment approaches whether they are seen at the largest comprehensive cancer center or the smallest community hospital.
The Community Clinical Oncology Program (CCOP) is a mechanism that links community cancer specialists and primary care physicians with clinical Cooperative Groups and Cancer Centers to conduct cancer treatment, prevention, and control clinical trials.
There are 52 CCOPs in 30 states, with 300 participating hospitals where
approximately 3,000 physicians cooperate to enter patients and individuals
at risk for cancer on NCI-approved clinical trials. An additional 10 minority-based
CCOPs are funded to enhance the participation of minority populations in
clinical trials research. These programs are located in nine states and
Puerto Rico, bringing an additional 42 hospitals and 350 physicians into
the clinical trials network. Through this network, individuals can access
state-of-the-art clinical research trials while remaining in their home
communities.
Each year the CCOPs enter over 4,000 patients onto cancer treatment clinical
trials (accounting for about one-third of all patients on NCI Phase III
treatment efficacy trials). An additional 4,000 participants are entered
onto cancer prevention and control clinical trials from the CCOP communities.
Support is also provided for university members and affiliates to participate
in prevention and control research. The CCOP covers the spectrum from testing
new combinations of anti-tumor drugs in cancer patients to testing the ability
of new agents to prevent first occurrences of cancer. Examples of the latter
are the Breast Cancer Prevention Trial (box on page 41) and the Prostate
Cancer Prevention Trial. CCOPs have also demonstrated successful interventions
for symptom management and continuing care of cancer patients, including
treatment for mucositis and hot flashes, common side effects of chemotherapy.
The program is rapidly evolving to include interventions for individuals
with specific molecular alterations associated with genetic cancer susceptibilities.
Linking the community, university researchers, and the NCI, the CCOP has
proven to be one of the critical paths for the dissemination of state-of-the-art
cancer treatment and prevention information. The CCOP research network is
well positioned to conduct the research of the future that will move oncologic
practice from the treatment of established disease to the management of
cancer risk.
NEXT SECTION... | PREVIOUS SECTION... | CONTENTS PAGE... |