Transcript Clinical Protocol Update 2011

MD Anderson Cancer Center
CCOP Research Base
Update 2011
Michael J. Fisch, MD, MPH, FACP
Chair, Department of General Oncology
Division of Cancer Medicine
[email protected]
Twitter: @fischmd, @JSupportOncol
Objectives
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•
•
•
•
Review our membership and accrual
Discuss some study data
Describe and discuss our active studies
Summarize CCOP Strategic Plan
Explore our future together
– What do we do well?
– What will be the indicators of success in the
future?
Active Treatment Protocols
Treatment: Active
2005-0839 (NCI 7341)
A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, with
Pegfilgrastim for the Treatment of Patients with Metastatic
Transitional Cell Carcinoma and Renal Insufficiency
Principal Investigator: Lance C. Pagliaro, MD, MD Anderson Cancer Center
Methodology: Single-arm phase II protocol
Patients with CrCL< 60 ml/min receive
• doxorubicin 40 mg/m2 IV over 20 min;
• paclitaxel 135 mg/m2 IV over 60 min;
• gemcitabine 900 mg/m2 IV over 90 min;
Pegfilgrastim 6 mg SC on day 1 or day 2
Courses repeated every 14 days
Patient Population:
Metastatic or unresectable transitional cell (TCC) carcinoma of bladder, urethra
or upper urinary tract.
Mixed TCC and variant histologies (small cell, squamous, adenocarcinoma,
sarcoma) are permitted if present in < 50% of the biopsy specimen.
Accrual 28 patients / Goal 72
Top Enrolling Sites: MD Anderson, Ozarks CCOP
Preliminary Results: Poster presented at GU ASCO February, 2011
Closed Treatment Protocols
ID00-156 (NCI 3410)
Treatment: CNPE
A Prospective Randomized Phase III Trial Comparing
Consolidation Therapy with or without Strontium-89 Following
Induction Chemotherapy in Androgen-Independent Prostate
Cancer
Principal Investigator: Shi-Ming Tu, MD, MD Anderson Cancer Center
Option 1
Ketoconazole/doxorubicin
Alternating with
Estramustine/vinblastine
Clinical
Response
16 weeks
Option 2
Prednisone/docetaxel
R
A
N
D
O
M
I
Z
E
Sr-89 plus doxorubicin x 6 weeks
Doxorubicin x 6 weeks
Patient Population: A total of 265 patients with androgen-independent prostate
cancer were enrolled. Closed to new patient entry 10/20/2010.
Top Enrolling CCOP Sites: MD Anderson – Orlando, Marshfield Clinic, Wichita
CCOP, Central Illinois CCOP
Preliminary Results: Pending
Treatment: CNPE
2004-0662 (NCI 6636)
A Randomized, Factorial-Design, Phase II Trial of Temozolomide
Alone and in Combination with Possible Permutations of
Thalidomide, Isotrentinoin and/or Celecoxib as Post-Radiation
Adjuvant Therapy of Glioblastoma Multiforme
Principal Investigator: Mark R. Gilbert, MD, M. D. Anderson Cancer Center
Temozolomide
1 TMZ
RT
CR,
PR
or
SD
None
2 TMZ + Thal
Reg. & Random.
Surgery or Biopsy
Max. =
5 wks
Other Agent(s)
3 TMZ + CRA
4 TMZ + Cel
5 TMZ + Thal/CRA
6 TMZ + Thal/Cel
PD
7 TMZ + CRA/Cel
Ineligible
CR=complete response, PR=partial response,
SD=stable disease,
PD=progressive disease
8 TMZ + Thal/CRA/Cel
TMZ-temozolomide; Thal-thalidomide;
CRA-cis-retinoic acid (isotretinoin); Cel-celocoxib
Patient Population:
178 patients with a diagnosis of
supratentorial glioblastoma
multiforme enrolled. Closed to
new patient entry 02/24/2011.
Top Enrolling CCOP Sites:
Atlanta CCOP, Kansas City
CCOP, Central Illinois CCOP
Preliminary Results: Pending
Treatment: CNPE
2004-0305 (NCI 6485)
A Phase II Study of Rituximab-CHOP with Pegylated Liposomal
Doxorubicin in Patients Older than 60 Years of Age with Untreated
Aggressive B-Cell Non-Hodgkin’s Lymphoma
Methodology:
Rituximab 375 mg/m2 IVPB on day 1, administered 1st
Cyclophosphamide 750 mg/m2 IVPB on day 1
Pegylated liposomal doxorubicin 40 mg/m2 IV over 1hr day 1
Vincristine 2.0 mg IV, day 1
Prednisone 40 mg/m2 PO days 1-5
GCSF 5 mcg/kg, SC daily, start on day 5, until neutrophil recovery (>3000/ul)
OR
Pegylated GCSF 6 mg SC x 1 (24 hours after chemotherapy)
Patient Population: At total of 80 patients, older than 60 years of age with
untreated aggressive B-cell NHL, enrolled. Closed to new patient entry
05/18/2009.
Top Enrolling CCOP Sites: Maimonides Medical Center, Grand Rapids CCOP
2004-0305 (NCI 6485)
Treatment: CNPE
A Phase II Study of Rituximab-CHOP with Pegylated Liposomal
Doxorubicin in Patients Older than 60 Years of Age with Untreated
Aggressive B-Cell Non-Hodgkin’s Lymphoma
Summary of Protocol Findings
– 80 patients were enrolled on the trial and evaluated for response,
cardiotoxicity, and myelosuppression.
– 74 patients were evaluable for response after 4 courses of therapy.
– 54 (73%) patients achieved a CR / 14 (19%) patients
achieved a PR
– The overall response rate was 92%.
– Response assessment after 8 courses of therapy was performed on
63 evaluable patients.
– The overall response rate for the 63 evaluable patients after
8 cycles was 89%.
2004-0305 (NCI 6485)
Treatment: CNPE
A Phase II Study of Rituximab-CHOP with Pegylated Liposomal
Doxorubicin in Patients Older than 60 Years of Age with Untreated
Aggressive B-Cell Non-Hodgkin’s Lymphoma
Summary of Protocol Findings
– Of the 80 patients enrolled, 12 (15%) patients reported grade 3
cardiac events, including hypotension (3), tachycardia (1),
hypertension (2), decreased ejection fraction (1), chest pain (2),
arrhythmia (3), coronary artery disease (1), acute coronary
syndrome and diastolic dysfunction (1), TIA (1), and pericarditis (1).
– Other Grade 3-4 toxicities reported in >10% of patients were:
fatigue (27), leucopenia (31), lymphopenia (35), neutropenia (34),
and anemia (12).
Treatment: CNPE
2006-0260 (NCI 7548)
Single-arm, Open-label, Phase II Trial of Rituximab plus
Sargramostim for the Treatment of Newly Diagnosed Follicular Bcell Lymphoma in Adults
New Principal Investigator Nathan Fowler, MD, MD Anderson Cancer
Center
Patient Population: A total of 52 patients with newly diagnosed follicular B cell
lymphoma were enrolled. Closed to new patient entry 05/01/2009.
Top Enrolling CCOP Sites: Wichita CCOP, Grand Rapids CCOP
2006-0260 (NCI 7548)
Treatment: CNPE
Single-arm, Open-label, Phase II Trial of Rituximab plus
Sargramostim for the Treatment of Newly Diagnosed Follicular
B-cell Lymphoma in Adults
Summary of Protocol Findings
– 52 pts were enrolled on study, and all were eligible for
assessment. The median age was 56 (31-78), and 62% were
male.
– 56% of patients had intermediate or high risk FLIPI. Fifteen
(29%) pts had bulky disease (>5cm), and 29 (56%) pts had
elevated B2M.
– Tolerance was good; and effects attributable to GM-CSF were
minor. Absolute granulocyte count (AGC) elevation above 15K
occurred in only 4% of pts; conversely, ≥ grade 3 neutropenia
occurred in 8 pts. No significant infections occurred.
2006-0260 (NCI 7548)
Treatment: CNPE
Single-arm, Open-label, Phase II Trial of Rituximab plus
Sargramostim for the Treatment of Newly Diagnosed Follicular
B-cell Lymphoma in Adults
Summary of Protocol Findings
– At 3 months, the overall response rate was 69%, including 23%
of pts with a CR. With continued follow up, response rates
improved (ORR 74%, CR 42%). Twenty four (46%) pts remain
in remission without further treatment. At a median follow up of
14 months the median PFS of all pts was 28 months, including
pts with bulky disease (median PFS of 16 mo). No difference in
PFS was observed when comparing FLIPI score (0-1) vs (2-3) or
B2M.
– Conclusion: Rituximab plus GM-CSF is well tolerated and
active in untreated pts with FL. There did not appear to be
significant difference in outcomes when comparing FLIPI
scores, although PFS was inferior in patients with bulky disease.
Randomized studies are required to determine whether this
combination is superior to rituximab as a single agent.
Active Cancer Control
Protocols
Cancer Control: Active
2004-0024 (NCI CCC01-06)
Chemotherapy and Mindfulness Relaxation: A Randomized Trial
at M. D. Anderson Cancer Center and M. D. Anderson Community
Clinical Oncology Program
Principal Investigators: Jon Hunter MD, Mount Sinai Hospital, Toronto
Lorenzo Cohen, PhD, MD Anderson Cancer Center
Community Co-Investigator: Dedra Glover, AS, CCRP, Scott & White CCOP
Methodology: Patients with newly-diagnosed cancer, who are about to
undergo chemotherapy, and give informed consent, will be randomly assigned
to one of three groups:
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•
•
Mindfulness Relaxation group [MR];
Relaxing Music group [RM] where participants will listen to music for the same
amount of time as the MR participants receive their intervention;
Standard Care control group where participants will receive standard medical
education on chemotherapy [SC].
Patient Population: The study population will consist chemotherapy naive cancer
patients schedule to undergo at least 4 cycles of chemotherapy treatment. Target accrual
400 subjects (including 25 on pilot). Current accrual 284.
Top Enrolling CCOP Sites: Scott & White CCOP, Michigan Cancer Research
Consortium, San Juan MBCCOP
2004-0024 (NCI CCC01-06)
Chemotherapy and Mindfulness Relaxation: A Randomized Trial
at M. D. Anderson Cancer Center and M. D. Anderson Community
Clinical Oncology Program
Additional training and intervention recording being held March 5, 2011.
Planned protocol revision March, 2011 to remove exclusion criteria
excluding patients with concrete planned immune therapy as part of
the their treatment regimen and/or within 3 months of completing
chemotherapy. Examples include GCSF, GMCSF,IL2, and/or
Interferon.
Cancer Control: Active
2006-0198 (NCI MDA 2006-0198)
CAM Use and Cancer
Principal Investigator: Patricia Ann Parker, PhD, MD Anderson Cancer Center
Random Assignment to Intervention or Waitlist Control
Enrollment of Nurses/Providers at Participating CCOPs
1 Week
Baseline Patient Assessment
Baseline Provider Assessment
Baseline Provider Assessment
CD/Video and Resource List
Provider and Patient Follow-Up Assessment
2 Weeks
Provider and Patient Follow-Up Assessment
Provider and Patient Follow-up Assessment
2 Months
Provider and Patient Follow-up Assessment
CD/Video and Resource List
Patient Population:. Oncology nurses with regular interactions with patients who are at least one week post
diagnosis of cancer and not greater than 6 months post treatment. 1360 target accrual.
Top Enrolling CCOP Sites: Metro-Minnesota CCOP, Central Illinois CCOP, Grand Rapids Clinical Oncology
Program, Boston Medical Center
2006-0198 (NCI MDA 2006-0198)
CAM Use and Cancer
Cancer Control: Active
Preliminary Findings – ASCO 2010
– Patients were 65% female, 86% non-Hispanic white,
average age of 59 (range 23-88), and 30% had a
college degree or higher.
– The most common cancers were breast cancer
(31%), lung cancer (12%), and colorectal cancer
(10%).
– 39% indicated that they have used one or more CAM
therapies following their cancer diagnosis.
2006-0198 (NCI MDA 2006-0198)
CAM Use and Cancer
Cancer Control: Active
Preliminary Findings Continued
– The most common categories of CAM used by
patients were:
•
•
•
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massage therapy (19%)
relaxation techniques (19%)
special diet (18%)
megavitamins (15%)
– Reasons for using CAM included:
• believes CAM beneficial (27%)
• to address the emotional and spiritual aspects of the disease
(23%)
• and to boost immune system (21%)
2006-0198 (NCI MDA 2006-0198)
CAM Use and Cancer
Cancer Control: Active
Preliminary Findings Continued
– Patients indicated that 9% of their physicians and 12% of nurses
had asked them about their use of CAM at that oncology visit.
– Twenty-one percent of patients reported that they initiated a
discussion with their providers about their use of CAM and the most
common responses were: encouraged me to continue (13%) and
was neutral (7%).
– Reasons for not telling healthcare practitioners about CAM use
included: my healthcare provider never asked (27%) and unsure if
CAM beneficial (18%).
2006-0198 (NCI MDA 2006-0198)
CAM Use and Cancer
Cancer Control: Active
Conclusions:
More than one third of patients indicated that they used some type
of CAM therapy and the majority of their providers did not ask them
about their CAM use. There remains considerable uncertainty
among patients about the role of CAM in the context of cancer care.
Twitter Time!
@fischmd
@JSupportOncol
@disparityreport
@DrLCohen
Promote Clinical Trials
Instantly share IRB approved clinical trial
flyers with a global audience
1.Uploaded approved flyer to web server
2.Shorten URL at http://bit.ly
3.Paste trial title and URL into Twitter
update box.
4.Done!
Why Bit.ly?
1.Shortens URL – Twitter limits you to 140
characters
2.Metrics. See how many people click on
your links.
This process works with any file type. It isn’t
just for clinical trials.
Focused Discussions
Hashtags are keywords that “tag “ a
conversation so that readers can easily find
all relevant tweets/comments. They’re great
for conferences!
Creating a hashtag is easy
1. Any word in your tweet that starts with a
pound sign is a hashtag. That’s all you have
to do
Twitter makes hashtags “clickable”
automatically. Clicking on one reveals the
entire conversation thread. You can create
your own or use others (as long as your
input is relevant).
Examples:
#mdacctrials
#pediatrics
#oncology
#ASPHO2010
2006-0841 (NCI MDA 2006-0841)
Cancer Control: Active
Randomized, Double-Blind, Placebo-Controlled Trial of Palonosetron/
Dexamethasone with or without Dronabinol for the Prevention of
Chemotherapy-induced Nausea and Vomiting after Moderately
Emetogenic Chemotherapy
Principal Investigator: P. K. Morrow, MD, MD Anderson Cancer Center
Steven Grunberg, MD, University of Vermont
Community Co-Investigator: Jeffery Giguere, MD, Greenville CCOP
Methodology:
Palonosetron 0.25 mg IV and dexamethasone 10 mg IV 30 minutes prior to chemo
administration. Randomized to take dronabinol 5 mg or matched placebo: 1 tablet by mouth
3 times a day for 5 days beginning 30 minutes before chemotherapy.
Follow-up physical examination and assessment between day14 through 28.
Primary endpoint will be Total Protection: No Vomiting, No Rescue Therapy and no Nausea
during the overall (0-120 hour) period.
Patient Population: Population will be 100 patients in each treatment group (200 patients
total).
Patients ≥18 years old, documented solid tumor, receiving first time chemotherapy. Currently
40 enrolled of 200 target accrual.
Enrolling CCOP Sites: Christus St. Frances Cabrini, Marshfield Clinic, Greenville CCOP
Cancer Control: Active
2006-0841 (NCI MDA 2006-0841)
Dronabinol/Placebo for the Prevention of CINV for
Moderately Emetogenic Chemotherapy
– Planned protocol revision March, 2011
– Allow the addition of regimens that give taxanes before Adriamycin
and/or Cytoxan
– Patients will be eligible after any number of cycles if
– taxane given as part of planned regimen such T→AC
– Patient has no N/V with taxane cycles
Cancer Control: Active
2008-0005 (NCI MDA 2008-0005)
Phase II, Randomized, Double Blind Comparison of CASAD vs.
Placebo for the Treatment and Prevention of Diarrhea in Patients
with Metastatic Colorectal Cancer
Principal Investigator: Bryan Kee, MD, M. D. Anderson Cancer Center
Methodology:
R
6 Weeks
CASAD -------------------------- Off Study/Optional Additional 6 Weeks
Placebo -------------------------- Off Study/Optional Additional 6 Weeks
CASAD / placebo will be provided by Salient Pharmaceuticals in
capsules that are taken as 2 capsules four times daily.
Recently revised and sent to sites for approval. Major changes: inclusion of patients with
ostomies, less restrictive lab requirements including ANC, and revision of UGT1A1
criteria.
Patient Population: A maximum of 100 patients will be randomized equally between
two arms, 50 per arm. Current accrual 56.
Enrolling CCOP Sites: Scott & White CCOP, Greenville CCOP, Columbia River CCOP
Cancer Control: Active
2007-0914 (NCI 2007-0914a)
A Multi-Center Study in Patients Undergoing Anthracycline-Based
Chemotherapy to Assess the Effectiveness of Using Biomarkers
to Detect and Identify Cardiotoxicity and Describe Treatment
Principal Investigator: Daniel J. Lenihan, MD, Vanderbilt University
Michael Fisch, MD, MD Anderson Cancer Center
Community Co-Investigator: Steven Wolff, MD, Meharry Medical College MBCCOP
Methodology:
The biomarkers (BNP and Troponin I) will be obtained as a point of care test with meter,
kits, controls and training provided by the protocol. Patients will be assessed during
each visit prior to each cycle of therapy until therapy completion and then at 6 and 12
months after the initiation of chemotherapy to identify cardiotoxicity.
Patient Population: A total of 830 patients starting a new anthracycline chemotherapy
regimen will be enrolled.
Enrolling CCOP Sites: Meters, kits and controls have been provided to 18 CCOP, Main
Member and academic sites. Additional meters will be available in March, 2011.
Currently 9 enrolled of 830 target.
2007-0914 (NCI 2007-0914a)
Cancer Control: Active
A Multi-Center Study in Patients Undergoing Anthracycline-Based
Chemotherapy to Assess the Effectiveness of Using Biomarkers
to Detect and Identify Cardiotoxicity and Describe Treatment
Eligible Diseases
• Most enrollments will be patients with Non-Hodgkin’s Lymphoma or
breast cancer
• Can be any disease being treated with a regimen that uses an
anthracycline including: Hodgkin’s, multiple myeloma, AML, ALL,
sarcoma, Kaposi’s sarcoma, bladder, SCLC, NSCLC, gastric,
ovarian and prostate
2007-0914 (NCI 2007-0914a)
Cancer Control: Active
A Multi-Center Study in Patients Undergoing Anthracycline-Based
Chemotherapy to Assess the Effectiveness of Using Biomarkers
to Detect and Identify Cardiotoxicity and Describe Treatment
Acceptable Anthracyclines
•
•
•
•
•
•
•
•
doxorubicin (Adriamycin)
doxorubicin liposomal (Doxil)
daunorubicin (Cerubidine)
daunorubicin liposomal (DaunoXome)
epirubicin (Ellence)
idarubicin (Idamycin)
mitoxantrone (Novantrone)
valrubicin (Valstar)
Cancer Control: Active
2007-0914 (NCI 2007-0914a)
A Multi-Center Study in Patients Undergoing Anthracycline-Based
Chemotherapy to Assess the Effectiveness of Using Biomarkers
to Detect and Identify Cardiotoxicity and Describe Treatment
Length of anthracycline regimen:
– Any, Q14 days, Q21 days, Q28 days
Anthracycline administration:
– Bolus or continuous infusion
Minimum anthracycline dose:
– any
Anthracycline regimen:
– single agent or multiple agent regimen
Cancer Control: Active
2007-0914 (NCI 2007-0914a)
A Multi-Center Study in Patients Undergoing Anthracycline-Based
Chemotherapy to Assess the Effectiveness of Using Biomarkers
to Detect and Identify Cardiotoxicity and Describe Treatment
Echocardiogram
– Prefer echocardiogram
– May use Muga scan if used consistently throughout
the trial
– Muga provides limited information, is more expensive,
and exposes patient to more radiation
Protocol revision in progress to clarify this point
Cancer Control: Active
2009-0288 (MDA 2009-0288)
Comparative Study of Oncologist Recommended, Home-Based
Exercise Program and Relaxation Training for Physical
Functioning and Symptom Control in Colon Cancer Patients
Principal Investigator: Karen Basen-Engquist, PhD, MD Anderson Cancer Center
Methodology:
N=150
R
16 Week Exercise Program
 Brief advice and letters from physician
 Brief telephone counseling
 Newsletters
 Written and video instructions for
resistance exercises, resistance bands
and pedometer
16 Week Relaxation Program
 Brief advice and letters from physician
 Brief telephone counseling
 Newsletters
 Written and audio instruction for
relaxation exercises
Patient Population: A total of 150 patients with metastatic colon cancer will be accrued
to this protocol.
Enrolling CCOP Pilot Sites: Wichita CCOP, Scott & White CCOP, Michigan Cancer
Research Consortium. Currently 2 enrolled of 150 target.
Closed Cancer Control
Protocols
2004-0728 (NCI CCC 03-27)
Cancer Control: CNPE
Prevention of Cisplatin- or Oxaliplatin-induced Peripheral
Neuropathy with Alpha-lipoic Acid: A Placebo-controlled Phase III
Trial
Principal Investigator: Ying Guo, MD, MD Anderson Cancer Center
Methodology:
Week
6±1
*Stratum
1
2
3
Total Prior
Cisplatin Rx*
<200 mg/m2
200-399 mg/m2
>400 mg/m2
Week
12±1
Total Prior
Oxaliplatin Rx*
<750 mg/m2
750-999 mg/m2
>1000 mg/m2
*For patients previously exposed to both drugs,the
following formula will be used. If “X mg/m2” of
Cisplatin and “Y mg/m2” of oxaliplatin had been
received, a “calculated prior cisplatin dose”, Z, will
be used for stratification in the cisplatin column.
Z=Y/3 + X
TID
Week
24±1
No treatment
No treatment
No treatment
Week 36 ±1
FACT/GOG-NTX, BPI, Functional Tests**
TID
Placebo
No treatment
FACT/GOG-NTX, BPI, Functional Tests**
TID
Placebo
ALA
600 mg
TID
FACT/GOG-NTX, BPI, Functional Tests**
Placebo
ALA
600 mg
TID
FACT/GOG-NTX, BPI, Functional Tests**
ALA
600 mg
TID
FACT/GOG-NTX, BPI, Functional Tests**
Randomization*
FACT/GOG-NTX, BPI, Functional Tests**
Platinum Therapy
(Schema overview for CCOP patients enrolled)
Week 48 ±1
**Functional Tests
• Time to button 6-hole shirt
• 50-foot walk at fastest speed
• Coin test
Chemotherapy cycles most likely
will be received by patients
Chemotherapy cycles possibly will
be received by patients
Patient Population: A total of 244 patients who were scheduled to receive chemotherapy that contains platinum in the
regimen were enrolled. Closed to new patient enrollment 11/02/2009.
Top Enrolling CCOP Sites: Metro-Minnesota CCOP, Wichita CCOP, Greenville CCOP, Marshfield Clinic, Christus St
Frances Cabrini Hospital
2004-0728 (NCI CCC 03-27)
Cancer Control: CNPE
Prevention of Cisplatin- or Oxaliplatin-induced Peripheral
Neuropathy with Alpha-lipoic Acid: A Placebo-controlled Phase III
Trial
Of 243 pts randomized, 121 pts (51%) completed
treatment for 12 weeks. At 24 weeks, only 34 evaluable
pts remained in the ALA group, and 36 in the placebo
group (p= 0.75). No statistical difference was noted in
dose intensity for the oxaliplatin arm of the ALA group
and the placebo group (median of 765 mg/m2 vs. 1020
mg/m2, p=0.18).
No significant differences were noted for either
FACT/GOG-NTX scores (p=0.70), neurotoxicity
(p=0.87), or best tumor responses between the 2 groups
(p=0.85).
Cancer Control: CNPE
2004-0728 (NCI CCC 03-27)
Prevention of Cisplatin- or Oxaliplatin-induced Peripheral
Neuropathy with Alpha-lipoic Acid: A Placebo-controlled Phase III
Trial
Conclusions:
• Oral ALA 600 mg PO TID was ineffective at preventing neurotoxicity
caused by oxaliplatin or cisplatin.
• Intense schedules of oral agents in the symptom/toxicity prevention
setting created adherence challenges due to pill size and frequency
of administration.
• Poor adherence might affect the power to detect ALA’s effectiveness
in this trial.
• Innovative drug delivery and trial designs are needed to further
explore alpha lipoic acid in the prevention and/or reduction of
chemotherapy-induced neuropathy.
Upcoming Protocols
Cancer Control: Proposed
2010-0547 (MDA 04-01)
A Phase III Prospective Randomized Trial of Acupuncture for
Treatment of Radiation-Induced Xerostomia in Patients with Head
and Neck Cancer
Principal Investigator: Joseph S. Chiang, MD, MD Anderson Cancer Center
Methodology:
Protocol Status: NCI Approved, IRB Approval Pending
Patient Population: A total of 150 patients who have received radiation for the treatment of head and
neck cancer will be enrolled.
Enrolling CCOP Sites: Sites should have a relationship with board certified acupuncturists who will
participate in training to do fixed acupuncture on a placebo controlled protocol.
2010-0547 (MDA 04-01)
Cancer Control: Proposed
A Phase III Prospective Randomized Trial of Acupuncture for
Treatment of Radiation-Induced Xerostomia in Patients with Head
and Neck Cancer
• Conference call/webinar to be held with interested sites in March,
2011.
• Call will be led by faculty from the Integrative Medicine Program
– Lorenzo Cohen, PhD
– Kay Garcia, MSN, MPH, DrPH (acupuncturist)
• Subcontracts will be implemented with participating sites to provide
pass through funds for acupuncture.
• Training videos will be provided for sites/acupuncturists
Cancer Control: Proposed
2011-0147(Not Yet Assigned)
A Phase I Study of Sublingual Anvirzel (Nerium Oleander) in
Advanced Non-Small Cell Lung Cancer
Principal Investigator: Richard Lee, MD, MD Anderson Cancer Center
Methodology: All subjects will receive SL Anvirzel dosing beginning 3 days
prior to starting chemotherapy. A total of four dose cohorts will be
evaluated (0.8, 1.6, 2.4, 3.2 ml/m2/day; SL q8hrs) with 7 patients per cohort.
Protocol Status: NCI Concept Submission Pending
Patient Population: Newly diagnosed advanced non-small cell lung cancer
patients scheduled to receive four cycles of carboplatin and docetaxel
chemotherapy. Total accrual goal of 28 patients.
Not Yet Assigned
Cancer Control: Proposed
Nano-curcumin in Breast Cancer Prevention in the
Contralateral Breast
Principal Investigator: Banu K. Arun, MD, MD Anderson Cancer Center
Protocol Status: NCI Concept Submission Pending
Patient Population: Breast Cancer Patients
Not Yet Assigned
Cancer Control: Proposed
BIG Study: Time Out for Reflection in the Course of
Chemotherapy
Principal Investigator: Jon Hunter, MD, Mount Sinai Hospital, Toronto,
Michael J. Fisch, MD Anderson Cancer Center, Lorenzo Cohen, PhD, MD
Anderson Cancer Center
Protocol Status: NCI Concept Submission Pending
Patient Population: Cancer Patients
CCOP Strategic Plan
• Incoroporate emerging science and novel
trial designs
– Survivorship, tx toxicities, risk assessment
• Use epi and biologic data from
underrepresented populations
• Improve clinical trial participation
Winning the future?
•
•
•
•
What are our biggest assets at MDACC?
What do we do best?
What should we do best (but aren’t yet)?
Creative ideas moving forward?
Thank You
[email protected]
(713) 563-0276