NCI-Sponsored Clinical Trials

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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, 2007
• NCCCP Launch

1 Division of Cancer Treatment Diagnosis 2
Division of Cancer Prevention
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Objectives

• Provide overview of NCI-sponsored clinical trials
  system
• Provide overview of clinical trials component of
  NCI Community Cancer Centers Program (NCCCP)

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NCI-Sponsored Clinical TrialsIntramural
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

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NIH Clinical Center in Bethesda, MDNCIs Center
for Cancer Research (CCR)
http//ccr.nci.nih.gov/
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NCIs CCR Clinical Trials
Of these treatment trials, breakdown by Phase
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NCI-Sponsored Clinical TrialsExtramural

• 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

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NCI Designated Cancer Centers Program

• 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)

• Research areas
• Basic research
• Clinical research
• Prevention, Control, Population/Behavioral
  Sciences

• http//cancercenters.cancer.gov/

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NCI-Sponsored Clinical TrialsExtramural

• 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

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CTEP by Numbers

• Currently sponsors over 140 INDs
• Approx. 11,000 registered investigators at over
  3,300 institutions
• Over 1000 active protocols
• 500 new protocols/year
• Approx. 33,000 patients accrued/year
• Over 80 collaborative agreements (CRADAs, CTAs,
  and CSAs) with pharmaceutical companies

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NCI-Sponsored Clinical Trials Cooperative Groups

• 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

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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)
• Childrens Oncology Group (COG)
• NCIC-CTG funding limited to participation in
  Intergroup trials

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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
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CTSU Cumulative Accrual by StudyAs of May 31,
2007 Top 14 Trials in Accrual ( Metastatic
Trial)
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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/

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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)

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NCI-Sponsored Clinical TrialsExtramural

• 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

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Parts of the CCOP Program
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Community Clinical Oncology Program

• Participating Physicians (3,385)
• 2,170 Physicians Accrue Trial Participants
• 1,215 Physicians Refer Trial Participants
• Participating Hospitals (395)

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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

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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

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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

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NCCCP Clinical Trials Components
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NCCCP Clinical Trials Components
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NCCCP Research QuestionsReducing 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 dont
  participate, dont randomize, wont refer
• CIRB utilization if yes, how is it working?
  and if no, why?
• Phase 2 studies problems solutions

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