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NCI-Sponsored Clinical Trials
Andrea Denicoff, RN, MS, ANP 1
Worta McCaskill-Stevens, MD 2
Jo Anne Zujewski, MD 1
Jeff Abrams, MD 1
June 25, 2007NCCCP Launch
1 Division of Cancer Treatment & Diagnosis2 Division of Cancer Prevention
Objectives
• Provide overview of NCI-sponsored clinical trials system
• Provide overview of clinical trials component of NCI Community Cancer Centers Program (NCCCP)
NCI-Sponsored Clinical Trials:Intramural & Extramural
• Intramural clinical trials– Conducted by scientists
employed by the Federal government
– Physicians, scientists, nurses, social workers, etc.
– Clinical Trials conducted on NIH main campus
• Extramural clinical trials– Conducted by scientists
who have been awarded grants through the NIH grant program
– Clinical trials conducted around the U.S. and in some foreign countries
NCI’s CCR Clinical Trials
Treatment
SpecimenCollection
NaturalHistory
ImagingScreeningFollow-upPsychosocial
Epidemiology
Phase I
Phase II
Phase I/IIPhase III
Pilot
Of these treatment trials, breakdown by Phase
• NCI-Designated Cancer Centers Program• Division of Cancer Treatment & Diagnosis
– Cancer Therapy Evaluation Program (CTEP)• Clinical Trials Cooperative Group Program
– Cancer Imaging Program• American College of Radiology Imaging Network
(ACRIN)
• Division of Cancer Prevention– Community Clinical Oncology Program (CCOP)– Minority-Based CCOP
NCI-Sponsored Clinical Trials:Extramural
http://cancercenters.cancer.gov/
NCI Designated Cancer Centers Program
Research areas• Basic research• Clinical research• Prevention, Control,
Population/Behavioral Sciences
Comprehensive Cancer Centers (39)
• Integrates research activities across all 3 major areas
Cancer Centers (24)• Scientific agenda
focuses on any one or two research areas
Total Centers (63)
• NCI-Designated Cancer Centers Program• Division of Cancer Treatment & Diagnosis
– Cancer Therapy Evaluation Program (CTEP)• Clinical Trials Cooperative Group Program
– Cancer Imaging Program• American College of Radiology Imaging Network
(ACRIN)
• Division of Cancer Prevention– Community Clinical Oncology Program (CCOP)– Minority-Based CCOP
NCI-Sponsored Clinical Trials:Extramural
• Currently sponsors over 140 INDsCurrently sponsors over 140 INDs
• Approx. 11,000 registered investigators Approx. 11,000 registered investigators
at over 3,300 institutionsat over 3,300 institutions
• Over 1000 active protocolsOver 1000 active protocols
• 500 new protocols/year500 new protocols/year
• Approx. 33,000 patients accrued/yearApprox. 33,000 patients accrued/year
• Over 80 collaborative agreements Over 80 collaborative agreements
(CRADAs, CTAs, and CSAs) with (CRADAs, CTAs, and CSAs) with
pharmaceutical companiespharmaceutical companies
CTEP by Numbers
• Cooperative Group Program (the “Groups”) is distinctive among NIH-supported clinical trials programs:– A clinical trials infrastructure that is continuously
available to test new therapeutic strategies – Consists of researchers at institutions affiliated with
the Groups who jointly develop and conduct trials in multi-institutional settings
– Flexible research agenda allows change of strategy in response to changing scientific opportunities and new discoveries
NCI-Sponsored Clinical Trials Cooperative Groups
NCI Cooperative Groups 10 Groups - 9 adult and 1 pediatric
• Multimodality:• Cancer and Acute Leukemia Group B (CALGB)• Eastern Cooperative Oncology Group (ECOG)• North Central Cancer Treatment Group (NCCTG)• Southwest Oncology Group (SWOG)• NCI of Canada – Clinical Trials Group (NCIC-CTG)**
• Specialty:• American College of Surgeons Oncology Group (ACOSOG)• National Surgical Adjuvant Breast & Bowel Project (NSABP)• Gynecologic Oncology Group (GOG)• Radiation Therapy Oncology Group (RTOG)• Children’s Oncology Group (COG)
** NCIC-CTG funding limited to participation in Intergroup trials
Scope
• United States and Canada– International Sites of US Groups
• Phase 3 adult cancer tx trials– Breast, GI, GU, GYN, Head & Neck, Leukemia,
Lung, Lymphoma, Sarcoma, others• Selected Phase 2 adult cancer tx trials• Over 65 active trials for adults with cancer• Over 22,000 enrollments since 1999
www.ctsu.org
CTSU Cumulative Accrual by Study:As of May 31, 2007 – Top 14 Trials in Accrual (* = Metastatic Trial)
Trial # Title SiteNCIC-MA.27 Exemestane vs Anastrozole Breast
CALGB-40101 CA (4 vs 6 cycles) vs Paclitaxel (4 vs 6 cycles) Breast
NSABP-B-39 Whole Breast Irradiation vs Partial Breast Irradiation Breast
NSABP-B-38 TAC vs DD AC-P vs DD AC-PG Breast
N0147 mFOLFOX6 vs mFOLFOX6 + Cetuximab Colon
PACCT1 TailoRx (Onco-Type DX) Breast
NSABP-B-35 Anastrozole vs Tamoxifen in DCIS Breast
S0221 Contin. AC+G vs Q 2 wk AC->P (Q 2 vs Q 12 wks) Breast
IBCSG-25-02 Role of Exemestane Plus GnRH Analogue Breast
IBCSG-24-02 Role of Ovarian Function Suppression & Exemestane Breast
NSABP-C-08 mFOLFOX6 vs mFOLFOX6 + Bevacizumab Colon
C80405 Chemo/BV vs Chemo/C225 vs Chemo/BV/C225 * CRC
NSABP-B-30 ACT vs AC vs ACT Breast
ACOSOG-Z9001 Imatinib vs Placebo GIST
What types of trials?Focus on developing treatment approaches
• Integrate new agents into standard regimens• Compare two or more novel approaches to an
accepted standard• Multimodality treatments• Emphasis on incorporating correlative sciences,
banking tissues and quality of life• Uncommon diseases or less common presentations
of common diseases
http://ctep.cancer.gov/
Selected NCI/CTEP-sponsored Group Trials Contributing to FDA-approved Indications for New Oncology Agents• 1991
– Fludarabine phosphate (SWOG)– Pentostatin (CALGB, SWOG)
• 1992– Paclitaxel (GOG, CALGB, ECOG, NCCTG, SWOG)
• 1993– Melphalan IV (CALGB)
• 1994– Pegaspargase (POG)
• 2001– Imatinib mesylate (COG, SWOG)
• 2004– Letrozole (NCIC, Intergroup)– Oxaliplatin (NCCTG, Intergroup); – Taxotere (SWOG)
• 2005– Nelarabine (COG, CALGB)
• 2006– Bevacizumab (ECOG, Intergroup); Rituxin (ECOG, Intergroup)– Herceptin (NSABP, NCCTG, Intergroup)
• NCI-Designated Cancer Centers Program• Division of Cancer Treatment & Diagnosis
– Cancer Therapy Evaluation Program (CTEP)• Clinical Trials Cooperative Group Program
– Cancer Imaging Program• American College of Radiology Imaging Network
(ACRIN)
• Division of Cancer Prevention– Community Clinical Oncology Program
(CCOP)– Minority-Based CCOP
NCI-Sponsored Clinical Trials:Extramural
Parts of the CCOP Program
CCOP MB-CCOP Research Base
Consortia of Hospitals & Practices that accrue patients to NCI trials
Institutions with >40% minority cancer patients that accrue to trials
Cooperative Groups
Cancer Centers
Design & conduct cancer control & prevention clinical trials
Community Clinical Oncology Program
• Participating Physicians (3,385)– 2,170 Physicians Accrue Trial Participants
– 1,215 Physicians Refer Trial Participants
• Participating Hospitals (395)
Community Clinical Oncology Program
• Impact of CCOP Participation in Treatment– 122,910 Patients on Treatment Clinical Trials– 1/3 Accrual to Cooperative Group Treatment
Trials– Results from Treatment Trials are Directly
Applicable to Patients in Their Communities– Community Physicians Who Participate in
Trials More Rapidly Adopt State-of-the-Art Treatment
Community Clinical Oncology Program
• Impact in Prevention– Over 93,380 Persons at Risk for Cancer on
Prevention Clinical Trials– CCOP Network Is the Vehicle to Conduct
Phase III Cancer Prevention Trials (all of which are peer reviewed)
– Community Physicians Practices Are the Forefront for Cancer Prevention
NCCCP: Clinical Trials Key Components
• Types of Clinical Trials– Treatment– Cancer Control and Symptom Reduction– Prevention
• Complexity of Trials– Phase 2 and 3– Multimodality capacity (i.e., RT+ surgery)– Ability to do translational type trials (specimen
submission-rich)• Connections to the Community
– Ca Ctrs, Academic Ctrs, CCOP/MBCCOPs, Coop Groups, Industry
– Referrals for phase 1– Emphasis on Minority Accrual
NCCCP: Clinical Trials Components
Area Clinical Trial Component
1. Community InputLocal advisory board to advise & assist pilot w/ varied membership, assist to increase awareness of importance of CTs
2. Types of TrialsTypes include treatment, prevention, cancer control & symptom amelioration
3. Trial ComplexityTrial complexity: multimodality, phase 2, translational trials, referral to phase I ctrs
4. CT InfrastructureInfrastructure & staff dedicated to working on clinical trials, education for new staff
5. Protocol Activation Timeliness
Track protocol receipt to activation, develop a log to measure timelines
NCCCP: Clinical Trials Components
6. CollaborationsCollaborations w/ Ca Ctrs, CCOPs, Groups, Academia, Industry
7. Outreach to the Underserved
Programs and outreach for minorities & underserved to participate in trials
8. Accrual TrackingTrack patient accrual to trials and keep log of reasons why or why not pts go or don't go on trials
9. CommunicationSystem of communication of clinical trial availability: internal and external
Area Clinical Trial Component
NCCCP Research Questions:Reducing Barriers to Clinical Trial Participation
• Ineligibility by disease, trial type, common cross-trial factors, gender, others
• Minority accrual issues – barriers, new research issues from the community
• Physician participation – reasons some docs don’t participate, don’t randomize, won’t refer
• CIRB utilization – if yes, how is it working? – and if no, why?
• Phase 2 studies – problems & solutions